Manager - Regulatory Affairs
Trenton Metro Area, New Jersey
- Bachelor s or Master s degree in a scientific discipline or equivalent.
- Candidate must possess at least 5 years of Regulatory experience in the pharmaceutical or biotechnology industry
- Must have a solid understanding of FDA regulations and ICH guidance s, as well as a comprehension of the drug development process.
- Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications
- Actively contribute to the development and implementation of regulatory strategy for assigned projects.
- Prepare, coordinate, manage regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.)
- Authoring/review/comment adjudication and finalization (submission and archival).
- Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.
- Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.