Manager, Regulatory Affairs Strategy - Oncology
Regeneron · Warren +1 more
RegulatoryFull-time$129k–$210kCompany career page
The apply link worked recently (not employer-confirmed).
What they're looking for
- MD, PhD, or PharmD degree with minimum 2+ years regulatory experience
- Experience preparing and managing regulatory filings and submissions
- Knowledge of US FDA and international pharmaceutical regulations and guidance
- Understanding of drug development processes and industry standard practices
- Strong written and verbal communication skills with meticulous attention to detail
- Experience coordinating with CROs on ex-US/ex-EU clinical trial applications preferred
What you'll be doing
- Coordinate preparation, submission, and maintenance of global regulatory submissions for clinical and nonclinical aspects
- Support coordination and preparation for regulatory agency meetings and briefing documents
- Track regulatory queries and commitments, collaborate on responses, provide status updates
- Represent regulatory interests in study-level activities and cross-functional team projects
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.