We are currently seeking a Senior RA Specialist for a TCM company based in Singapore which involves working closely with regulatory bodies and internal teams to ensure adherence to all applicable regulations and standards. The ideal candidate will be responsible for navigating the complex regulatory environment, contributing to the development of effective regulatory strategies, and ensuring that all TCM products meet the highest quality standards.
Reporting to: Head of R&D & RA
Location: Singapore
The role:
Serve as the primary regulatory contact between the company and authorities like HSA, managing product applications, registrations, certifications for new market entries, and maintaining necessary licenses in accordance with local regulations while ensuring regulatory procedures and systems are properly implemented.
Compile and prepare technical documentation and product details, ensuring all materials related to registration, manufacturing, and promotion meet regulatory standards in Singapore.
Build and maintain strong relationships with key external agencies; coordinate meetings and engage in negotiations with regulatory bodies when needed.
Support the export of pharmaceutical products from China to Singapore, ensuring compliance with export regulations, and assist in the evaluation of proprietary Chinese medicine formulations while providing strategic insights to internal teams.
The experience:
Master's degree or higher in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, or a related discipline & ideally with three years of experience in the field
- Ideally with a background as a registered pharmacist with the Singapore Pharmacy Council with experience in proprietary Chinese medicines.
Ideally with expertise in handling regulatory matters, with a solid understanding of the regulatory landscape and its impact on strategy and execution.
Familiarity with drug development practices, including relevant rules, regulations, and guidelines.
How to apply:
Please provide your CV to Shash Prasanan at shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document/pdf format.
EA License No. 23S1885
Registration No. R24121011
