Associate Manager, Regulatory Affairs Strategy - Oncology
Regeneron · Tarrytown +1 more
RegulatoryFull-time$110k–$179kCompany career page
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What they're looking for
- MD, PhD, or PharmD degree with relevant internship, fellowship, post-doc, or industry experience
- Oncology experience preferred
- Knowledge of US FDA and international pharmaceutical guidance and drug development regulations
- Experience with CRO management for ex-US/ex-EU clinical trial activations preferred
- Strong attention to detail and project prioritization skills
- Excellent written, oral, and interpersonal communication abilities in English
What you'll be doing
- Coordinate preparation, submission, and management of global regulatory filings including INDs, CTAs, and annual reports
- Assist with Agency meeting coordination and briefing document preparation
- Track regulatory agency queries and commitments, collaborate with experts on written responses
- Support study-level regulatory activities and cross-functional product development meetings
- Research and develop regulatory strategy for assigned clinical development programs
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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