Manager, Regulatory Affairs Strategy - Oncology
Regeneron · Tarrytown +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 affairs experience
- Experience preparing regulatory filings and developing regulatory documents
- Knowledge of US FDA and international pharmaceutical regulations and guidance
- Understanding of drug development processes and industry standard practices
- Experience managing ex-US/ex-EU CTAs with CROs preferred
- Strong written and verbal communication skills
- High attention to detail and project prioritization ability
What you'll be doing
- Coordinate preparation, submission, and maintenance of global regulatory submissions for INDs, CTAs, and annual reports
- Assist coordination and preparation for agency meetings and briefing documents
- Lead tracking of regulatory agency queries and commitments with written responses
- Provide regulatory representation for study-level activities and cross-functional team participation
- Support Global Regulatory Liaison in all regulatory affairs aspects of therapeutics development
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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