We are currently looking for an RA Manager for a pharmaceutical manufacturing company with a legacy of over 50 years in the industry. This Singapore-based role entails collaborating closely with regulatory authorities and internal teams to ensure compliance with all relevant regulations and standards. The successful candidate will be responsible for navigating complex regulatory landscapes, supporting the development of effective regulatory strategies, and ensuring that all products meet stringent quality requirements.
Reporting to: VP of International Business
Location: Singapore
The role:
Accountable for conducting pre-project registration assessments, securing product registration approvals for both innovative and generic drugs in the Asia-Pacific region, and overseeing the product's lifecycle after it enters the market.
Tasked with performing due diligence, coordinating across departments, and managing related activities during the project initiation phase for international clients.
- Responsible for consistently monitoring international pharmaceutical regulations, developing appropriate submission strategies, and ensuring adherence to regulatory standards.
The experience:
Ideally with a Master's degree or above in Pharmacy, Clinical Medicine, or related fields.
Ideally with experience with overseas registration, familiar with the entire registration process, and well-versed in clinical, non-clinical, pharmacological work processes.
- Ideally with experience in generic drug registration, with knowledge of the registration process for innovative drugs in Singapore and the Asia-Pacific region.
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
