- Experience 5 year +
- Degree Bachelor's Degree
- Language EnglishGood
- Skill Unlimited
Position: Manager, China Regulatory Affairs
Location: Shanghai, China
Report to: Director of Regulatory Affairs
l Develop regulatory strategy and action plan for internal or external projects, in compliance with local regulations, and guidelines and SOPs.
l Compile registration dossier and ensure timely regulatory submission. Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.
l Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
l Collaborate closely with internal groups and external clients in developing R&D strategies and/or commercial strategies.
l Provide regulatory expertise to the R&D projects including biologics and small molecular drug products.
l Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Coast Drug Control Institutes).
l Continuously monitor the development of regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly evaluated and well communicated.
l Medical/pharmacy/life sciences background, B.S. or above
l Over 5 years regulatory experience in a globe leading pharmaceutical company
l Strong network with regulatory agencies, e.g. CDE, CFDA, NICBPB
l Be familiar with regulations and guidelines in CFDA, FDA and EU
l Excellent communication skills and convincing skills in both Chinese and English
l Good leadership and project management skills
l Good team player
l Open attitude, Willing to meet challenges
Qualified candidates are welcomed to send your CV to email@example.com .