My client is a global name in the biotechnology industry, dealing with the treatment of infectious diseases and now seek an experienced RA Manager.
The Regulatory Affairs Manager will devise CMC processes and the necessary documentation.
- Formulate CMC strategies and prepare documentation for regulatory submission
- Lead new product registration and serve as the focal point between regulatory authorities such as HAS and the RA and Clinical team
- Develop regulatory strategies for current and new therapeutic areas based on regulatory guidelines
- Work closely with internal and external stakeholders to align on guidelines and support portfolio goals.
- Masters or PhDs in chemistry, biotechnology or equivalent with at least 5 years' experience in Regulatory affairs.
- Strong fundamental knowledge in existing RA guidelines for new drug applications.
- Prior expertise in drafting submission documentation related to CMC fillings.
- Experience in complete management of regulatory submissions such as tracking amendments, communications etc.
- Ability to developing certification and conduct training programs.
- Excellent communication and negotiation skills.
- Experience with registration and licensing (BLA).
Please send your resume in WORD format by clicking the apply button below or contact Jason Nathan on +65 6701 1517 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R21101268 (Jason Nathan).