职位编号 Job Code: CNCD03
职位 Position: Regulatory Affairs Manager
部门 Department：Clinical Development
汇报关系 Reports to: Vice President, Clinical Development, Asia
办公地点 Location: Remote
职位目标 Purpose or Objective of Position:
This role is to provide input to new product registration strategy, perform the coordination and preparation of regulatory submissions to ensure the alignment and compliance with registration requirement in Asian countries, and keep abreast of regulatory procedures and changes.
主要职责 Key Responsibilities：
- Well understands regulations, local guidelines & changing regulatory environment relating to new drug registration.
- Understand pre-clinical, clinical and manufacturing drug development knowledge and provide constructive and solid input to clinical development plan and activities in Asian countries.
- Manage all regulatory activities on all products and pipelines including but not limited to IND and NDA submissions / approvals, either by direct operation or by oversight CRO’s operation.
- Build sustainable relationships internally and externally to ensure effectively collaboration and regulatory procedures.
- Anticipate potential regulatory hurdles, identify the policy influence and works out innovative strategy in coping with the situation or leveraging the opportunities.
- Effectively work with external expertise to optimize regulatory strategy and tactics.
- Good teamwork to resolve conflict, difficulties and challenges.
- Bachelor or above degree in Pharmacy, Medical, Biology or related field.
- At least 5 years Regulatory experience in pharmaceutical company.
- Experience in regulatory submission / approvals on innovative biologics / chemical drug or biosimilar products.
- Above 3 years’ experience in managing non-clinical trials or CMC studies is also acceptable if lacking of regulatory experience.
- Mother-tone level Chinese and fluent English in oral and written
- Good computer skill in Microsoft ware