Explore opportunities in regulatory affairs, a field crucial for ensuring compliance and ethical standards across various industries. This area involves navigating complex legal frameworks, preparing documentation, and interacting with regulatory bodies. Professionals in regulatory affairs play a key role in product development and market access, making it a dynamic and impactful career path. Job roles may include 3 Regulatory Affairs jobs in Thailand
Regulatory Affairs Manager
Pathum Wan, Bangkok
AbbVie
Posted 4 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 Associate
บริษัท ไบโอฟาร์ม เคมิคัลส์ จำกัด
Posted today
Job Viewed
Job Description
วันนี้
- คุณสมบัติพื้นฐาน
- งานประจำ- 0 - 1 ปี- กรุงเทพและปริมณฑล- ปริญญาตรีหรือสูงกว่า- 20,000 - 30,000 บาท/เดือน- หน้าที่และความรับผิดชอบ
- Providing support and expertise in area of healthcare product registration to business development team.
- Ensuring all company licenses have been approved and renewal.
- Support post-marketing vigilance activities (includes Pharmacovigilance/PV Training/Adverse Event Report/Recalls/Complaints etc.)
- Ensuring regulatory and quality assurance compliance according to GDP standard, Corporate SOPs, Laws and Regulations etc.
- Ensure compliance with Thai FDA rules and regulations (Drug Act), GDP, GPP, Other relevant laws including PDPA for both Warehouse and Head Office.
- Maintains databases for tracking purpose. Follows-up to ensure that required documents/records are received.
- Reviews and verifies documents/records for accuracy and audit readiness.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Assists with various projects as assigned by Manager/Director.
- Other duties as assigned.
- คุณสมบัติ
- Bachelor’s Degree in pharmacy or related scientific field required.
- Minimum 0-1 years of working experiences in regulatory affairs or related field (New graduates are welcome!)
- Knowledge on FDA rules and regulation concerning Drugs, Foods, Medical Devices, and Cosmetics, preferable.
- Knowledge on regulatory processes ACTD documentation.
- Knowledge on Pharmaceutical product license requirement.
- Knowledge on QA or Quality Management System, preferable.
- Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat, desktop publishing software, document management, and database software.
- Detail oriented, proactive, effective task planning, ability work under deadlines, strong organizational skills required and coordination of activities.
- Strong troubleshooting skills highly desirable.
- Outstanding interpersonal and communication (written and verbal) skills.
- Good command both Thai and English.
ดูคุณสมบัติเพิ่มเติม
- สวัสดิการ
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- ประกันอุบัติเหตุ
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เที่ยวประจำปี หรือเลี้ยงประจำปี
- โบนัสตามผลงาน/ผลประกอบการ
ดูสวัสดิการเพิ่มเติม
- คุณสมบัติพื้นฐาน
- งานประจำ- 0 - 1 ปี- กรุงเทพและปริมณฑล- ปริญญาตรีหรือสูงกว่า- 20,000 - 30,000 บาท/เดือน- หน้าที่และความรับผิดชอบ
- Providing support and expertise in area of healthcare product registration to business development team.
- Ensuring all company licenses have been approved and renewal.
- Support post-marketing vigilance activities (includes Pharmacovigilance/PV Training/Adverse Event Report/Recalls/Complaints etc.)
- Ensuring regulatory and quality assurance compliance according to GDP standard, Corporate SOPs, Laws and Regulations etc.
- Ensure compliance with Thai FDA rules and regulations (Drug Act), GDP, GPP, Other relevant laws including PDPA for both Warehouse and Head Office.
- Maintains databases for tracking purpose. Follows-up to ensure that required documents/records are received.
- Reviews and verifies documents/records for accuracy and audit readiness.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Assists with various projects as assigned by Manager/Director.
- Other duties as assigned.
- คุณสมบัติ
- Bachelor’s Degree in pharmacy or related scientific field required.
- Minimum 0-1 years of working experiences in regulatory affairs or related field (New graduates are welcome!)
- Knowledge on FDA rules and regulation concerning Drugs, Foods, Medical Devices, and Cosmetics, preferable.
- Knowledge on regulatory processes ACTD documentation.
- Knowledge on Pharmaceutical product license requirement.
- Knowledge on QA or Quality Management System, preferable.
- Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat, desktop publishing software, document management, and database software.
- Detail oriented, proactive, effective task planning, ability work under deadlines, strong organizational skills required and coordination of activities.
- Strong troubleshooting skills highly desirable.
- Outstanding interpersonal and communication (written and verbal) skills.
- Good command both Thai and English.
ดูคุณสมบัติเพิ่มเติม
- สวัสดิการ
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- ประกันอุบัติเหตุ
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เที่ยวประจำปี หรือเลี้ยงประจำปี
- โบนัสตามผลงาน/ผลประกอบการ
ดูสวัสดิการเพิ่มเติม
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Specialist - Thailand
ConvaTec
Posted 23 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.
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