Director Regulatory Affairs

Director, Regulatory Affairs | Hybrid in NJ

A well-funded, clinical-stage biotech 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 work and make an impact by leading one of the company's most important assets.

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