8 Regulatory Affairs Manager jobs in Thailand
Regulatory Affairs Manager
Pathum Wan, Bangkok
AbbVie
Posted 5 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
+ Lead Allergan Aesthetic portfolio to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and to quality.
+ Regulatory activities, including new product registrations, renewal registration, variations and maintenance of registered products, for Allergan Aesthetics with AbbVie's policies compliance.
+ Procedures are expected to meet statutory, quality and business requirements.
+ Develop regulatory strategies and provide regulatory assessment for submission and approval plan.
+ Responsible for review and approval of advertising/promotional material from regulatory perspective
+ Support business and cross functional teams from regulatory perspective.
+ Support maintenance of local SOPs and ensuring compliance with regulations.
+ Monitor emerging trends regarding industry regulations.
+ Other regulatory projects and tasks assigned by RA Head.
CORE JOB RESPONSIBILITIES
Product Registration and maintenance
+ Primary contact with Regulatory Authority in Thailand for responsible products.
+ Facilitate communication between Area Regulatory lead and the local regulatory authority.
+ Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
+ Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.
+ Execute manage new product submissions, line extensions, variations, renewal registration according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Regulatory Authority.
+ Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
+ Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution and sale & marketing of Allergan Aesthetic products.
+ Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
+ Provide regular registration status to RA Head.
+ Communicate regulatory issues and evaluate the impact on the business to management, Business Unit, where applicable.
+ Manage labelling changes, artwork development and artwork approval of packaging material components.
Business Support
+ Work cross-functionally as required to meet business needs.
+ Support local business teams in activities such as tenders, as required, from a regulatory perspective.
+ Review and provide input and approval on promotional materials, from regulatory perspective.
+ Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
+ Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
+ Monitor the progress of marketing applications and provide management with a monthly registration status in (Sales & Operation Planning) S&OP meeting and during brand team meetings as applicable.
+ Implement regulatory activities in support of lifecycle management in line with business needs.
+ Collaborative with supply chain to ensure timely maintenance of product labels to ensure compliance to Abbvie requirements, and continuity in supply.
Processes
+ Maintain global systems and databases to ensure that all relevant regulatory information is updated.
+ Manage Allergan Aesthetic regulatory systems and SOPs to comply the corporate policy.
+ Lead or participate in projects to streamline RA processes to increase productivity, where applicable.
Compliance
+ Responsible for review and approval of advertising and promotional materials and campaign/events from regulatory perspective, collaborating with business partners.
+ Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
+ Update local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority requirements.
+ Provide timely and accurate input to regulatory assessments of products where requested.
+ Support sales and marketing colleagues by providing adequate and relevant regulatory information.
+ Hold pharmacist licence for company, if required and where applicable.
Regulatory Intelligence
+ Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
+ Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.
+ Monitor on changes related to the Regulatory Authority on law & regulations affecting registration, manufacture, distribution, and sale & marketing of AbbVie products.
+ Maintain an awareness of country's regulatory legislation and assess its impact on AbbVie's business
People/Contractor Management (where applicable)
+ Lead and provide guidance to team member/contractor to prioritize and meet target goals and objectives in a timely manner
Qualifications
+ University degree in Pharmacy or Pharmaceutical Science, or related disciplines.
+ At least 7 years of regulatory experience in the pharmaceutical industry and/or medical device industry. Knowledge of Thailand regulations in medical device. Pharmaceutical knowledge would be an added advantage.
+ Excellent analytical skills and ability to think strategically with local, regional, and global perspectives.
+ High affinity in regulatory affairs intelligence with strong ability to provide sound advices and suggestions to the team.
+ Ability to manage cross-functional team to achieve the goals and objectives with excellence of interpersonal skills, enthusiastic and a team player with positive attitude.
+ Result oriented, agility and ability to work in a fast-paced environment
+ Strong communication skills - both oral and written and proficiency in English and Thai to su the market requirements.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
+ Lead Allergan Aesthetic portfolio to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and to quality.
+ Regulatory activities, including new product registrations, renewal registration, variations and maintenance of registered products, for Allergan Aesthetics with AbbVie's policies compliance.
+ Procedures are expected to meet statutory, quality and business requirements.
+ Develop regulatory strategies and provide regulatory assessment for submission and approval plan.
+ Responsible for review and approval of advertising/promotional material from regulatory perspective
+ Support business and cross functional teams from regulatory perspective.
+ Support maintenance of local SOPs and ensuring compliance with regulations.
+ Monitor emerging trends regarding industry regulations.
+ Other regulatory projects and tasks assigned by RA Head.
CORE JOB RESPONSIBILITIES
Product Registration and maintenance
+ Primary contact with Regulatory Authority in Thailand for responsible products.
+ Facilitate communication between Area Regulatory lead and the local regulatory authority.
+ Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
+ Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.
+ Execute manage new product submissions, line extensions, variations, renewal registration according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Regulatory Authority.
+ Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
+ Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution and sale & marketing of Allergan Aesthetic products.
+ Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
+ Provide regular registration status to RA Head.
+ Communicate regulatory issues and evaluate the impact on the business to management, Business Unit, where applicable.
+ Manage labelling changes, artwork development and artwork approval of packaging material components.
Business Support
+ Work cross-functionally as required to meet business needs.
+ Support local business teams in activities such as tenders, as required, from a regulatory perspective.
+ Review and provide input and approval on promotional materials, from regulatory perspective.
+ Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
+ Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
+ Monitor the progress of marketing applications and provide management with a monthly registration status in (Sales & Operation Planning) S&OP meeting and during brand team meetings as applicable.
+ Implement regulatory activities in support of lifecycle management in line with business needs.
+ Collaborative with supply chain to ensure timely maintenance of product labels to ensure compliance to Abbvie requirements, and continuity in supply.
Processes
+ Maintain global systems and databases to ensure that all relevant regulatory information is updated.
+ Manage Allergan Aesthetic regulatory systems and SOPs to comply the corporate policy.
+ Lead or participate in projects to streamline RA processes to increase productivity, where applicable.
Compliance
+ Responsible for review and approval of advertising and promotional materials and campaign/events from regulatory perspective, collaborating with business partners.
+ Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
+ Update local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority requirements.
+ Provide timely and accurate input to regulatory assessments of products where requested.
+ Support sales and marketing colleagues by providing adequate and relevant regulatory information.
+ Hold pharmacist licence for company, if required and where applicable.
Regulatory Intelligence
+ Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
+ Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.
+ Monitor on changes related to the Regulatory Authority on law & regulations affecting registration, manufacture, distribution, and sale & marketing of AbbVie products.
+ Maintain an awareness of country's regulatory legislation and assess its impact on AbbVie's business
People/Contractor Management (where applicable)
+ Lead and provide guidance to team member/contractor to prioritize and meet target goals and objectives in a timely manner
Qualifications
+ University degree in Pharmacy or Pharmaceutical Science, or related disciplines.
+ At least 7 years of regulatory experience in the pharmaceutical industry and/or medical device industry. Knowledge of Thailand regulations in medical device. Pharmaceutical knowledge would be an added advantage.
+ Excellent analytical skills and ability to think strategically with local, regional, and global perspectives.
+ High affinity in regulatory affairs intelligence with strong ability to provide sound advices and suggestions to the team.
+ Ability to manage cross-functional team to achieve the goals and objectives with excellence of interpersonal skills, enthusiastic and a team player with positive attitude.
+ Result oriented, agility and ability to work in a fast-paced environment
+ Strong communication skills - both oral and written and proficiency in English and Thai to su the market requirements.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Manager
Bangkok, Bangkok
Abbott Laboratories
Posted today
Job Viewed
Job Description
**_MAIN PURPOSE OF ROLE_**
- Summarize the main purpose of the role._
Experienced professional individual contributor that works under limited supervision.
**_ MAIN RESPONSIBILITIES_**
As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
**_ QUALIFICATIONS_**
**_ Education_**
- Education Level_
- Major/Field of Study_
- Or_
- Education Level_
Associates Degree (± 13 years)
**_ Experience/Background_**
- Experience_
- Experience Details_
Minimum 1 year
**_ Licenses and Certifications_**
- License/Certification_
**_ Language Proficiency_**
- Language_
- Proficiency_
- Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role._
- Summarize the main purpose of the role._
Experienced professional individual contributor that works under limited supervision.
**_ MAIN RESPONSIBILITIES_**
As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
**_ QUALIFICATIONS_**
**_ Education_**
- Education Level_
- Major/Field of Study_
- Or_
- Education Level_
Associates Degree (± 13 years)
**_ Experience/Background_**
- Experience_
- Experience Details_
Minimum 1 year
**_ Licenses and Certifications_**
- License/Certification_
**_ Language Proficiency_**
- Language_
- Proficiency_
- Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role._
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Manager
Bangkok, Bangkok
Abbott Laboratories
Posted today
Job Viewed
Job Description
**_MAIN PURPOSE OF ROLE_**
- Summarize the main purpose of the role._
Experienced professional individual contributor that works under limited supervision.
**_ MAIN RESPONSIBILITIES_**
As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
**_ QUALIFICATIONS_**
**_ Education_**
- Education Level_
- Major/Field of Study_
- Or_
- Education Level_
Associates Degree (± 13 years)
**_ Experience/Background_**
- Experience_
- Experience Details_
Minimum 1 year
**_ Licenses and Certifications_**
- License/Certification_
**_ Language Proficiency_**
- Language_
- Proficiency_
- Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role._
- Summarize the main purpose of the role._
Experienced professional individual contributor that works under limited supervision.
**_ MAIN RESPONSIBILITIES_**
As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
**_ QUALIFICATIONS_**
**_ Education_**
- Education Level_
- Major/Field of Study_
- Or_
- Education Level_
Associates Degree (± 13 years)
**_ Experience/Background_**
- Experience_
- Experience Details_
Minimum 1 year
**_ Licenses and Certifications_**
- License/Certification_
**_ Language Proficiency_**
- Language_
- Proficiency_
- Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role._
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Manager (1 Year Contract)
Siam Makro Pcl.
Posted today
Job Viewed
Job Description
Regulatory.
TFDA.
Food.
Job.
Ensure product management comply with local regulation and company compliance policy.
Support all necessary regulatory information to related function.
Responsible for product registration, amendment, label and advertisement.
Maintaining and secure the regulatory database.
Build/enhance good relationship with TFDA and other government authorities and internal stake holder.
Manage the product registration of new countries and new phases.
Support Store on Product registration, Store Licenses, Store projects on Food Safety and all RA projects.
**Qualifications**:
Bachelor's degree in science, Pharmacy or related field.
Minimum 5 years working experience in regulatory affairs area especially in food.
Strong interpersonal, negotiation, communication and presentation skills.
Good command of written & spoken English including computer literacy.
High ability to learn with good attitude.
Ability to effectively manage projects and good human relation.
**Job skills required**: English, Negotiation, Compliance
TFDA.
Food.
Job.
Ensure product management comply with local regulation and company compliance policy.
Support all necessary regulatory information to related function.
Responsible for product registration, amendment, label and advertisement.
Maintaining and secure the regulatory database.
Build/enhance good relationship with TFDA and other government authorities and internal stake holder.
Manage the product registration of new countries and new phases.
Support Store on Product registration, Store Licenses, Store projects on Food Safety and all RA projects.
**Qualifications**:
Bachelor's degree in science, Pharmacy or related field.
Minimum 5 years working experience in regulatory affairs area especially in food.
Strong interpersonal, negotiation, communication and presentation skills.
Good command of written & spoken English including computer literacy.
High ability to learn with good attitude.
Ability to effectively manage projects and good human relation.
**Job skills required**: English, Negotiation, Compliance
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Assistant Manager
Bangkok, Bangkok
Galderma
Posted today
Job Viewed
Job Description
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Responsibilities:
- Complete all regulatory submissions (NPD and renewal) and follow up until approval in accordance with the business timeline- Complete the pre-registration activities, e.g. review of regulatory requirements, agency communication and discussion to ensure timely submission- Ensure product lifecycle management compliance and submit the variations to Government Authorities in timely manner and implement the change within the defined timeline-
- Review the regulatory artworks and promotional materials in regulatory perspective- Organize, update and maintain regulatory information, tracking and repository in timely manner- Develop, maintain good relationship with Government Authorities, and keep company updated about governmental rules and regulations that will impact on company business- Submit the response of inquiries and information requests from Government Authorities in timely manner- Develop, review and revise regulatory SOPs and procedures as assigned- Perform other special projects as assigned
Requirement:
- Pharmacist with a license- 3-5 years experiences in regulatory affairs experience in medical devices or/and drugs / cosmetics product- Fluent/communicable in English
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Responsibilities:
- Complete all regulatory submissions (NPD and renewal) and follow up until approval in accordance with the business timeline- Complete the pre-registration activities, e.g. review of regulatory requirements, agency communication and discussion to ensure timely submission- Ensure product lifecycle management compliance and submit the variations to Government Authorities in timely manner and implement the change within the defined timeline-
- Review the regulatory artworks and promotional materials in regulatory perspective- Organize, update and maintain regulatory information, tracking and repository in timely manner- Develop, maintain good relationship with Government Authorities, and keep company updated about governmental rules and regulations that will impact on company business- Submit the response of inquiries and information requests from Government Authorities in timely manner- Develop, review and revise regulatory SOPs and procedures as assigned- Perform other special projects as assigned
Requirement:
- Pharmacist with a license- 3-5 years experiences in regulatory affairs experience in medical devices or/and drugs / cosmetics product- Fluent/communicable in English
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Specialist - Thailand
ConvaTec
Posted 24 days ago
Job Viewed
Job Description
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care.
With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more please visit will be responsible for the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. The incumbent will provide other regulatory support as assigned by supervisor.
The responsible countries include Thailand and other South East Asia countries as assigned by supervisor.
**Key duties and responsibilities:**
+ Ensure regulatory compliance with local laws.
+ Prepare and submit documents to health authorities for product approvals.
+ Support regulatory strategy and update based on changes.
+ Handle post-approval activities and product lifecycle tasks (renewals, changes, listings).
+ Review and approve product changes, labeling, and promotional materials.
+ Communicate with health authorities to ensure timely approvals.
+ Participate in audits and support post market reporting.
+ Maintain regulatory databases and provide documents for reimbursement/tenders.
+ Stay updated on regulatory changes and inform relevant teams.
+ Collaborate with supply chain, marketing, and country manager on regulatory projects
**Skills & Experience:**
+ Bachelor's degree in related field or higher; RAC certification is a plus.
+ Minimum 3 years in medical device regulatory affairs.
+ Experience with regulatory submissions and quality systems.
+ Knowledge of GDPMDS and ISO13485 preferred.
+ Strong communication skills in English
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
#LI-SA1
#LI-Hybrid
**Beware of scams online or from individuals claiming to represent Convatec**
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
**Notice to Agency and Search Firm Representatives**
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
**Already a Convatec employee?**
**If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**
With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more please visit will be responsible for the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. The incumbent will provide other regulatory support as assigned by supervisor.
The responsible countries include Thailand and other South East Asia countries as assigned by supervisor.
**Key duties and responsibilities:**
+ Ensure regulatory compliance with local laws.
+ Prepare and submit documents to health authorities for product approvals.
+ Support regulatory strategy and update based on changes.
+ Handle post-approval activities and product lifecycle tasks (renewals, changes, listings).
+ Review and approve product changes, labeling, and promotional materials.
+ Communicate with health authorities to ensure timely approvals.
+ Participate in audits and support post market reporting.
+ Maintain regulatory databases and provide documents for reimbursement/tenders.
+ Stay updated on regulatory changes and inform relevant teams.
+ Collaborate with supply chain, marketing, and country manager on regulatory projects
**Skills & Experience:**
+ Bachelor's degree in related field or higher; RAC certification is a plus.
+ Minimum 3 years in medical device regulatory affairs.
+ Experience with regulatory submissions and quality systems.
+ Knowledge of GDPMDS and ISO13485 preferred.
+ Strong communication skills in English
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
#LI-SA1
#LI-Hybrid
**Beware of scams online or from individuals claiming to represent Convatec**
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
**Notice to Agency and Search Firm Representatives**
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
**Already a Convatec employee?**
**If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Executive (Contract)
Bangkok, Bangkok
BD
Posted today
Job Viewed
Job Description
**Job Description Summary**: To ensure all registration submissions in Thailand according to Curie project are completed and met timeline as planned.
**Who We Are**
**Main Responsibilities**:
Responsible for all activities associated with regulatory clearance for all products in the country which includes:
- Work closely with the Business Leads from the various BU to determine which products need to be included for registration
- Work with BD division RA (BURA) to obtain necessary information / documents (e.g. CFG / CFS, etc.)
- Compile documentation and ensure completeness and quality of registration dossier
- Submit registration dossier and follow through until regulatory clearance is obtained (if applicable)
- Review and Prepare change notifications or amendments of registered products for submission
- Submit change notifications or amendments of registered products (if required)
- Maintain and update list of registered products in the applicable platforms (e.g. SharePoint, RA Shared folders, RIM etc.)
- Support any post-market field action reporting to local MOH (if applicable) Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate.
- Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Undertake additional projects and tasks as assigned by the supervising manager
- Provide regulatory inputs for and participate in GDP audits where appropriat
- Build a good relationship with in-country junior regulators at the least (where appropriate)
**Job Requirements**:
- Degree in Pharmaceutical/Science/Biomedical or equivalent
- Minimum 2 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry.
- Knowledge of quality systems or regulatory requirements preferably related to medical devices.
- Good team player
- Have good problem-solving acumen
- Independent, meticulous and communicates well
- Proficient in Microsoft Office (Word, PowerPoint, Excel)
**Culture and Benefits**
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
**How To Apply**
**Primary Work Location**: THA Bangkok - The Offices at Central World
**Additional Locations**:
**Work Shift**:
**Who We Are**
**Main Responsibilities**:
Responsible for all activities associated with regulatory clearance for all products in the country which includes:
- Work closely with the Business Leads from the various BU to determine which products need to be included for registration
- Work with BD division RA (BURA) to obtain necessary information / documents (e.g. CFG / CFS, etc.)
- Compile documentation and ensure completeness and quality of registration dossier
- Submit registration dossier and follow through until regulatory clearance is obtained (if applicable)
- Review and Prepare change notifications or amendments of registered products for submission
- Submit change notifications or amendments of registered products (if required)
- Maintain and update list of registered products in the applicable platforms (e.g. SharePoint, RA Shared folders, RIM etc.)
- Support any post-market field action reporting to local MOH (if applicable) Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate.
- Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Undertake additional projects and tasks as assigned by the supervising manager
- Provide regulatory inputs for and participate in GDP audits where appropriat
- Build a good relationship with in-country junior regulators at the least (where appropriate)
**Job Requirements**:
- Degree in Pharmaceutical/Science/Biomedical or equivalent
- Minimum 2 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry.
- Knowledge of quality systems or regulatory requirements preferably related to medical devices.
- Good team player
- Have good problem-solving acumen
- Independent, meticulous and communicates well
- Proficient in Microsoft Office (Word, PowerPoint, Excel)
**Culture and Benefits**
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
**How To Apply**
**Primary Work Location**: THA Bangkok - The Offices at Central World
**Additional Locations**:
**Work Shift**:
This advertiser has chosen not to accept applicants from your region.
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Regulatory Affairs Executive (Contract)
Bangkok, Bangkok
BD
Posted today
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Job Description
Job Description Summary
To ensure all registration submissions in Thailand according to Curie project are completed and met timeline as planned.
**Job Description**:
Who We Are
Main Responsibilities:
Responsible for all activities associated with regulatory clearance for all products in the country which includes:
- Work closely with the Business Leads from the various BU to determine which products need to be included for registration
- Work with BD division RA (BURA) to obtain necessary information / documents (e.g. CFG / CFS, etc.)
- Compile documentation and ensure completeness and quality of registration dossier
- Submit registration dossier and follow through until regulatory clearance is obtained (if applicable)
- Review and Prepare change notifications or amendments of registered products for submission
- Submit change notifications or amendments of registered products (if required)
- Maintain and update list of registered products in the applicable platforms (e.g. SharePoint, RA Shared folders, RIM etc.)
- Support any post-market field action reporting to local MOH (if applicable) Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate.
- Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Undertake additional projects and tasks as assigned by the supervising manager
- Provide regulatory inputs for and participate in GDP audits where appropriat
- Build a good relationship with in-country junior regulators at the least (where appropriate)
Job Requirements:
- Degree in Pharmaceutical/Science/Biomedical or equivalent
- Minimum 2 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry.
- Knowledge of quality systems or regulatory requirements preferably related to medical devices.
- Good team player
- Have good problem-solving acumen
- Independent, meticulous and communicates well
- Proficient in Microsoft Office (Word, PowerPoint, Excel)
Culture and Benefits
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
How To Apply
Primary Work Location
THA Bangkok - The Offices at Central World
Additional Locations
Work Shift
To ensure all registration submissions in Thailand according to Curie project are completed and met timeline as planned.
**Job Description**:
Who We Are
Main Responsibilities:
Responsible for all activities associated with regulatory clearance for all products in the country which includes:
- Work closely with the Business Leads from the various BU to determine which products need to be included for registration
- Work with BD division RA (BURA) to obtain necessary information / documents (e.g. CFG / CFS, etc.)
- Compile documentation and ensure completeness and quality of registration dossier
- Submit registration dossier and follow through until regulatory clearance is obtained (if applicable)
- Review and Prepare change notifications or amendments of registered products for submission
- Submit change notifications or amendments of registered products (if required)
- Maintain and update list of registered products in the applicable platforms (e.g. SharePoint, RA Shared folders, RIM etc.)
- Support any post-market field action reporting to local MOH (if applicable) Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate.
- Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Undertake additional projects and tasks as assigned by the supervising manager
- Provide regulatory inputs for and participate in GDP audits where appropriat
- Build a good relationship with in-country junior regulators at the least (where appropriate)
Job Requirements:
- Degree in Pharmaceutical/Science/Biomedical or equivalent
- Minimum 2 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry.
- Knowledge of quality systems or regulatory requirements preferably related to medical devices.
- Good team player
- Have good problem-solving acumen
- Independent, meticulous and communicates well
- Proficient in Microsoft Office (Word, PowerPoint, Excel)
Culture and Benefits
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
How To Apply
Primary Work Location
THA Bangkok - The Offices at Central World
Additional Locations
Work Shift
This advertiser has chosen not to accept applicants from your region.
7