The Manager Regulatory Affairs will be responsible for the following:
- Leading the preparation and filing of regulatory applications (IND, NDA, BLA).
- Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.
- Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.
- Leading the preparation of responses to questions from Regulatory Authorities.
- Developing and maintaining regulatory timelines as well as tracking deliverables to timelines in order to ensure regulatory submission timelines are met.
- Participating in the development of regulatory strategies
- Providing strategic input and regulatory advice to the project teams on development programs.
- Proactively identifying project issues and implementing appropriate regulatory strategies in order to mitigate risks.
- Interfacing with global regulatory authorities
- Conducting FDA meetings as necessary to support regu
- latory filings and applications
- Preparing and coordinating Briefing Packages for meetings with FDA.
The Manager Regulatory Affairs needs a minimum of 5 years of experience in Regulatory Affairs in the Pharmaceutical industry.