Director Regulatory Affairs
Director, Regulatory Affairs | Hybrid in NJ
A well-funded, publicly traded biopharmaceutical company focused on oncology is hiring a Director, Regulatory Affairs to support its clinical development pipeline. This is a hands-on role on a small regulatory team, ideal for someone who wants to stay close to the actual work rather than manage people.
What you'll be doing:
- Owning the authoring of regulatory materials for FDA and ex-US health authority interactions
- Contributing directly to clinical regulatory content and strategy on standard-track submissions
- Preparing for and participating in Health Authority meetings
- Working cross-functionally with Clinical, Safety/PV, CMC Regulatory, and Regulatory Operations
- Partnering closely with a Senior Director on some of the company's most important active programs
What we're looking for:
- 10+ years of regulatory affairs experience
- Oncology experience (5+ years) - small molecule, biologics, or mixed modality background all considered
- Hands-on experience with an NDA, BLA, or MAA submission
- Strong working knowledge of FDA regulations; EU and APAC a plus
- Strong cross-functional collaborator - this role requires real ability to influence and align stakeholders, not just technical depth
- Based in the NY/NJ metro area
Logistics:
- Hybrid: 3 days/week onsite in Jersey City, NJ
- Compensation: $210,000-$260,000 base + bonus
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