Join our dynamic team where innovation and care converge in a culture that values continuous learning, diversity and transformative career development. Underpinned by THRIVE with Zuellig Pharma, our commitment to transforming the way we grow, care and succeed together as one organization, we are dedicated to helping our people make a meaningful impact in healthcare.
Regulatory Affairs Associate
Thailand
Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.
DUTIES AND RESPONSIBILITIES
- Manage all activities related to Regulatory Affairs (pre-submission, submission, and life cycle maintenance).
- Ensure compliance of regulatory requirements, company & principles policies.
- Handle the whole process of registration project of Drug Products, Medical Devices, Foods and Cosmetic under FDA requirements and committed timeline.
- Classify the product to be complied with particular Thai FDA Channels.Plan, coordinate and manage for lot release to be ready for sales on time.
- Prepare Certificates of Analysis translation for responsible products.
- Response to questions and/or comments from FDA authorities.
- Consult, review, and advise on promotional materials to be published under marketing and sales activities such as advertising, leaflets, sales promotion programs and all activities related to Regulatory Affairs.Support the team to ensure objective’s meets.
- Ensure all regulatory information and guideline are up to date.
- Review new statement, circulate to concerned parties.
- Review all customer questionnaires/queries and ensure all answers meet company’s policy and regulations within committed timeline.
- Management of Pharmacovigilance activities as back up for responsible products carried out within Thailand according to principal and FDA regulations.
- Update regulatory submission tracking record and prepare monthly registration status reports for responsible products.
- Providing support and expertise in area of healthcare product registration to internal steak holder and principles as requested.
Qualification:
- Bachelor’s degree in Pharmacy or relevant fields.
- Minimum 2 years of experiences in area of regulatory affairs for drug and healthcare products.
- Have knowledge on FDA rules and regulationsHave knowledge on Pharmaceutical & Healthcare products registration requirements and maintenance of licenses.
- Experiences in registering Oncology, Biological products, New Generics and Biosimilars will be an advantage.
- Fluency in English.
- Growth mindset
What We Offer:
• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect.