Title: Senior Manager/Director Regulatory Affairs
A global biologics company is seeking an experienced Senior Manager/Director Regulatory Affairs to serve as the US FDA lead and play an integral role in developing and executing regulatory strategy and planning. This person will have the responsibility for maintenance of the licenses/authorizations for existing marketing authorizations and will provide post-market support of market-released products.
The Senior Manager/Director Regulatory Affairs will be responsible to…
- Serve as the US FDA Regulatory Affairs representative
- Interact with the FDA regarding product-specific issues and serve as the FDA point of contact
- Lead and maintain product registration strategy and planning in the US
- Maintain understanding of US regulatory environment
- Identify and mitigate potential risks in regulatory filings
- Provide regulatory support to cross functional project teams
- Prepare and review regulatory dossier
- Provide post market support
- Review labeling to ensure compliance with regulatory requirements
- Supervise and train junior level employees
- Requires travel to FDA site
Qualifications:
- 8+ years of experience in pharmaceuticals Regulatory Affairs
- Must have experience working on biosimilar/biologics products
- Ability to travel abroad and to FDA as needed
- The ideal candidate will be fluent in Korean
