79 Regulatory Affairs Manager jobs in Thailand

Our client, a Leading multinational pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to lead and oversee all regulatory activities in Thailand. This role is critical in ensuring compliance, driving successful product registrations, and maintaining strong relationships with the Thai FDA.

• Manage all activities related to product registration for pharmaceutical products, OTC, medical devices, cosmetics, food, chemicals, and biologics.
• Review, evaluate, and coordinate product documentation, ensuring all requirements for product registration are met.
• Ensure all submissions and approvals comply with local laws, regulations, and guidelines.
• Communicate approvals or regulatory changes effectively across relevant internal and external stakeholders.
• Build and maintain strong relationships with government agencies, proactively influencing and responding to regulatory developments.
• Identify regulatory and quality risks, proposing preventive and corrective strategies for product registrations.
• Stay updated on evolving regulations, laws, and competitive landscapes to provide timely regulatory intelligence.
• Manage and coordinate Pharmacovigilance activities in compliance with Thai FDA requirements.
• Ensure proper documentation of registered products.
• Lead, develop, and coach the Regulatory Affairs team to achieve goals and deliver key objectives on time.

• Bachelor's or Master's degree in Pharmacy.
• Licensed Pharmacist (mandatory).
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry (PHC/CHC).
• Proven experience with product registration for pharmaceuticals, biologics, medical devices, cosmetics, foods, and related categories.
• Strong working relationship with the Thai FDA and demonstrated success in regulatory negotiations.
• Excellent networking, communication, and result-oriented skills.
• Strong analytical and problem-solving skills with the ability to resolve regulatory challenges.
• Proficient in MS Office and fluent in English (spoken, written, and read).

The ideal candidate will have:

• In-depth knowledge of regulatory compliance and local requirements for product registration.
• Strong leadership, team management, and coaching skills.
• Ability to analyze complex regulatory issues and deliver practical solutions.
• Proactive mindset with strong influence and stakeholder management abilities.

**About the company

Amway** is the #1 direct selling company worldwide, offering 250+ high-quality products that promote health and well-being.

We have over 14,000 employees worldwide, with more than 1,000 based in Thailand.

Amway Thailand is the 5th highest sales market for Amway worldwide and the number 1 direct selling business in Thailand.

Duties & Responsibilities

• Ensure product registration and compliance meet launching schedule for Nutrition/Food category.
• Provide technical services and required support to affiliates.
• Build trust, credibility, and maintain good relationships on behalf of Amway with related entities - academic, government and private sectors.
• Provide technical support and collaboration with other  internal departments.

Experience& Qualification:

• Degree in Food Science or Health and Nutrition, with major in Chemistry, Biology, Bio-Chemistry, Pharmacy or related field. Advanced degrees are highly desirable.
• Proven track record of experience in regulatory matters
• 10 years' experience and up in consumer products in the field of Regulatory Affairs. (Food supplement)
• Must be proficient working with business software.
• Experience working for multi-national corporations is preferred.
• Must have knowledge of consumer product regulations and standards.
• Good communication in English.

Benefits

• Global Collaboration and Cross-Cultural Experience
• Fixed Bonus / Variable Bonus and Annual Merit
• Onsite Fitness / Outer Fitness Reimbursement
• Learning & Development Programs

How to apply

Click APPLY or reach out to Khun Natchanan

Regulatory Affairs Manager (Regional)

Location: Bang Phli, Samut Prakan

Are you a regulatory affairs professional with expertise in the chemical or pharmaceutical industry, particularly in cleaning and hazardous substances? Join our global team as a Regulatory Affairs Manager - ASEAN and take a leading role in driving compliance, innovation, and collaboration across Southeast Asia.

• Provide regulatory guidance and support for commercial, technical, and product-related activities.
• Manage product registrations, labeling, SDS, and documentation in line with ASEAN regulatory frameworks.
• Build and maintain strong relationships with regulatory authorities, industry bodies, and strategic partners.
• Support supply chain and manufacturing partners with compliance requirements.
• Supervise and develop regulatory staff as assigned.
• Partner with business development and R&D teams on new product initiatives.
• Deliver regular reports and updates to the Global Regulatory Affairs Manager.
• Travel within ASEAN as required.

• Minimum 5 years' experience in Regulatory Affairs, with at least 2 years at Regional supervisor level.
• Strong background in the chemical or pharmaceutical industry, ideally in cleaning products or hazardous substances.
• Proven track record managing regional regulatory affairs across ASEAN.
• Strong knowledge of ASEAN compliance requirements for pesticides, hazardous substances, or related chemical regulations.
• Excellent stakeholder management and problem-solving skills.
• Fluent in English, both written and spoken; additional ASEAN languages are an advantage.
• Ability to work independently and effectively within a global matrix organization.

American Taiwan Biopharm Co., Ltd.
(
ATB
)
: is a joint venture between TTY Biopharm Co., Ltd. (Taiwan) and a group of American investors. With over 25 years of experience in pharmaceutical industry, ATB has recently emerged as one of the leading marketing-driven pharmaceutical companies in Southeast Asia (SEAs), by offering all stakeholders high-quality & affordable pharmaceutical products, aiming to improve people's quality of life & accessibility across the region.

Key Responsibilities

• Prepare, submit and follow up by-priority ANDA & NDA submissions and develop regulatory strategy to secure the approvals in timely manner.
• Manage post-approval activities, including license maintenance, renewals, GMP clearance, change of control processes, and pharmacovigilance support.
• Review and prepare packaging artwork, label & PIL per approval.
• Arrange regulatory documents in tidy manner for audit and legal reference.
• Update regulatory regulations and evaluate the impacts on business.
• Develop strategic relationships with authorities to ensure smooth approvals.
• Liaise with local RA agencies in SEAs to accelerate the approvals.
• Lead, coach and support RA associates on regular basis.
• Coordinate & support commercial, business development & supply chain teams, from regulatory perspective, such as tenders, advertising approvals, in-licensing projects, importation, etc.

Qualifications

• Bachelor of Pharmacy & minimum 7 years of RA experience both ANDA & NDA.
• Analytical & problem-solving abilities, aligned with SEAs regulatory frameworks.
• Result-oriented & business-driven mindsets with leadership.
• Good interpersonal skills & ability to collaborate across functions in the organization.
• Excellent proficiency in English together with communication skills.

The company offers competitive remuneration packages for the right candidate. Only the right candidate will be informed for the final interview. Your CV shall be strictly kept confidential. If you're ready to explore this challenging opportunity, please share your CV to Tel

ZURU is on a mission to disrupt industries, challenge the status quo, and catalyze change through radical innovation and advances in automation. This is in play in different pillars of the company: ZURU Toys are re-imagining what it means to play; ZURU Tech is shaping a better future by leading the next building revolution; and ZURU Edge is pioneering new-generation FMCG brands to better serve modern consumers.
Founded in 2003 by EY Entrepreneur of the Year and World Entrepreneur Hall of Fame brothers Nick and Mat Mowbray, ZURU has quickly grown to a team of over 5,000 direct and indirect members across more than 30 international locations.
One of the largest toy companies in the world, our globally recognized and award-winning brands include Bunch O Balloons, Mini Brands, XSHOT, Rainbocorns, and Smashers. Our global FMCG brands include MONDAY Haircare, Rascals, NOOD, BONKERS, and Gumi Yum Surprise.
For more information, visit

Responsibilities

• Regulatory Compliance Management
• Developing and providing recommendation to Marketing and Product development team since early step of work from conception to commercialization and deliver right first time of regulatory compliance.
• Managing product registration and amendment with local and exported products to ensure product license is delivered on time.
• Product labelling and Claims
• Providing scientific evidence and dossier to support product claims
• Reviewing and providing approve on product claims on pack, communication channels ensuring compliance with regulations.
• New factory set up
• Leading and providing support to factory team for new Pet foods factory registration with Thai government to ensure smooth transition and get a license on time.
• Stakeholder and Authority Engagement
• Being support in applying for and renewing relevant permits and license.
• Monitoring regulatory changes and new developments in Pet foods regulations to ensure up-to-date information providing to stakeholders.
• Providing training to new team members and re-fresh training to current team members to ensure everyone having good understanding of update Pet food regulations.

Qualifications

• Bachelor's or Master's degree in animal science, Animal feed production, agricultural industry or other related.
• Having good understanding of AAFCO, FIDIAF and NRC are preferable.
• At least 3-5 years of experience in registering animal feed products or similar products.
• Good communication skills with people at many levels. Have a good relationship working with the DLD.
• Having knowledge in FDA Compliance/FDA registration of products, animal feed registration, submit applications for Health Certificate, Certificate of Free sales with relevant agencies such as the Department of Livestock Development (DLD) etc.
• Having knowledge and experience HACCP, GMP, ISO9001, Food safety.
• Good skills in using MS Office computers.
• Having a good personality and human relations. Have skills in planning and data analysis.
• Able to solve immediate problems well and receive pressure from performing well.

At ZURU, we have cultivated a high-performing culture that encourages excellence. Our team works towards ambitious goals, learning, performing, and improving together, all while having fun. We empower talented individuals to do their best work every day.

At ZURU, you get out what you put in. You are responsible for driving your own career and we provide the platform to achieve it. As ZURU is on such a fast growth trajectory, there are opportunities here that you won't find anywhere else.

We recognise that ZURU's success stems from our people and you can only be at your best when you are looking after yourself. ZURU encourages all our team members to invest in their wellbeing by providing an array of benefits and tools.

ZURU – Tomorrow Reimagined

Role and Responsibility

1. Provide accurate and consistent regulatory recommendations, decisions, and feedback

2. Prepare regulatory strategies for new devices and post market changes

3. Clearly communicate strategies to RA Manager and core teams

4. Prepare regulatory filings for new products, as well as significant post-market changes

5. As necessary, review complex regulatory issues with RA Manager

1. Identify risks within regulatory strategies and clearly communicate risks to project teams and RA Manager

7. Negotiate and lead meeting directly with government entities on regulatory filings at the reviewer level.

8. Lead and author multiple types of substantive regulatory filings such as PMAs, 510(k), EU Technical Document

9. Follow QS procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, MDSAP and UKCA

10. Review labeling, packaging and promotional materials to ensure regulatory compliance.

11. Maintain records of regulatory submissions and approvals.

12. Ensure the products comply with global regulations and reach the market legally and efficiently.

Additional responsibilities as assigned by the Regulatory Affairs Manage

Responsibilities :

• Prepare and submit regulatory dossiers for Herbal products, Pharmaceutical products and Cosmetic registration in Thailand and export to international markets.
• Verify the company's product licenses, to be according to the latest Thai laws, and FDA regulations, to maintain the legal status of the company's product licenses, for selling in Thailand, and to monitor, and update the specifications of all products, according to the continuously changing requirements set by the FDA, and to coordinate with team.
• Manage Certificate of Pharmaceutical Product/Herbal Product application, Free Sale Certificates and import/export permits.
• Manage and suggest to Marketing team about label, advertising materials, and product claims to ensure compliance with Thailand regulation.
• Provide document support to the Sales and Product Teams, correctly, and appropriately, in a timely manner.
• Follow up and update current FDA regulations to inform with team.
• Collaborate with team to ensure smooth products registration.

Qualifications :

• Bachelor's degree in Pharmaceutical Science
• Minimum of 5-7 years of experience in regulatory affairs within the Herbal products, Pharmaceutical products and Cosmetic is preferred.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.

สวัสดิการ สิทธิประโยชน์อื่นๆ นอกเหนือที่กฎหมายกำหนด

• ทำงาน 5 วันต่อสัปดาห์
• Flexible working hour (สามารถเลือกเวลาเข้างานได้ตั้งแต่ น.)
• Welcome Set 1 ชุด
• สิทธิการเข้าใช้สนามปั่นจักรยานเซียงเพียวไบค์พาร์คฟรีสำหรับพนักงาน และ ส่วนลด 50% สำหรับผู้ติดตาม
• ส่วนลดซื้อผลิตภัณฑ์ฯลฯ

เงินออม & ค่าครองชีพ

• การจ่ายเงินโบนัส
• การจ่ายเงินสะสมเข้ากองทุนสำรองเลี้ยงชีพให้พนักงาน
• การจัดทำประกันสุขภาพ
• ค่ารักษาพยาบาลสมาชิกครอบครัว
• การตรวจสุขภาพประจำปี
• การฉีดวัคซีนไข้หวัดใหญ่ประจำปี
• แจกยูนิฟอร์มพนักงานประจำปี
• กระเช้าเยี่ยมสำหรับพนักงานเจ็บป่วยและคลอดบุตร
• เงินช่วยเหลือค่าทำศพกรณีพนักงานเสียชีวิต ฯลฯ
• พัฒนาศักยภาพ
• การจัดฝึกอบรมภายในให้ความรู้ด้านต่างๆ
• การจัดส่งพนักงานไปอบรมภายนอก

พัฒนาศักยภาพ

• การจัดฝึกอบรมภายในให้ความรู้ด้านต่างๆ
• การจัดส่งพนักงานไปอบรมภายนอก
• การสัมมนาสถานที่ (outing trip) ประจำปี ฯลฯ
• การสัมมนาประจำปี ฯลฯ

Responsibilities :

• Prepare and submit regulatory dossiers for Herbal products, Pharmaceutical products and Cosmetic registration in Thailand and export to international markets.
• Verify the company's product licenses, to be according to the latest Thai laws, and FDA regulations, to maintain the legal status of the company's product licenses, for selling in Thailand, and to monitor, and update the specifications of all products, according to the continuously changing requirements set by the FDA, and to coordinate with team.
• Manage Certificate of Pharmaceutical Product/Herbal Product application, Free Sale Certificates and import/export permits.
• Manage and suggest to Marketing team about label, advertising materials, and product claims to ensure compliance with Thailand regulation.
• Provide document support to the Sales and Product Teams, correctly, and appropriately, in a timely manner.
• Follow up and update current FDA regulations to inform with team.
• Collaborate with team to ensure smooth products registration.

Qualifications :

• Bachelor's degree in Pharmaceutical Science
• Minimum of 5-7 years of experience in regulatory affairs within the Herbal products, Pharmaceutical products and Cosmetic is preferred.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.

สวัสดิการ สิทธิประโยชน์อื่นๆ นอกเหนือที่กฎหมายกำหนด

• ทำงาน 5 วันต่อสัปดาห์
• Flexible working hour (สามารถเลือกเวลาเข้างานได้ตั้งแต่ น.)
• Welcome Set 1 ชุด
• สิทธิการเข้าใช้สนามปั่นจักรยานเซียงเพียวไบค์พาร์คฟรีสำหรับพนักงาน และ ส่วนลด 50% สำหรับผู้ติดตาม
• ส่วนลดซื้อผลิตภัณฑ์ฯลฯ

เงินออม & ค่าครองชีพ

• การจ่ายเงินโบนัส
• การจ่ายเงินสะสมเข้ากองทุนสำรองเลี้ยงชีพให้พนักงาน
• การจัดทำประกันสุขภาพ
• ค่ารักษาพยาบาลสมาชิกครอบครัว
• การตรวจสุขภาพประจำปี
• การฉีดวัคซีนไข้หวัดใหญ่ประจำปี
• แจกยูนิฟอร์มพนักงานประจำปี
• กระเช้าเยี่ยมสำหรับพนักงานเจ็บป่วยและคลอดบุตร
• เงินช่วยเหลือค่าทำศพกรณีพนักงานเสียชีวิต ฯลฯ
• พัฒนาศักยภาพ
• การจัดฝึกอบรมภายในให้ความรู้ด้านต่างๆ
• การจัดส่งพนักงานไปอบรมภายนอก

พัฒนาศักยภาพ

• การจัดฝึกอบรมภายในให้ความรู้ด้านต่างๆ
• การจัดส่งพนักงานไปอบรมภายนอก
• การสัมมนาสถานที่ (outing trip) ประจำปี ฯลฯ
• การสัมมนาประจำปี ฯลฯ