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