Regulatory Affairs Manager
The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.
Responsibilities:
- Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
- Serve as primary RA contact on project teams to support product development.
- Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
- Respond to FDA queries and deficiencies.
- Provide guidance to RA Associates and aid in development of team.
- Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
- Monitor and interpret new and evolving regulations and assess impact on company products.
- Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
- Oversee adverse event reporting process and ensure compliance with reporting requirements.
- Support due diligence activities, licensing, and partnerships.