Senior Director, Regulatory Affairs — Boston, MA
We’re partnering with a leading Boston-based oncology biotech to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline.
This is a high-impact leadership role for an experienced regulatory professional with a proven track record in oncology, IND/CTA strategy, and global regulatory interactions.
What you’ll own:
- Lead regulatory strategy for oncology clinical programs from early development through commercialization
- Manage IND/IMPD, CTA, and BLA/NDA submission planning and execution
- Build and maintain strong relationships with FDA, EMA, and global health authorities
- Provide regulatory leadership across cross-functional teams (clinical, CMC, safety, medical affairs)
- Drive alignment on regulatory strategy, timelines, and risk mitigation
- Mentor and develop regulatory team members
What we’re looking for:
- 10+ years of regulatory experience in oncology (biologics preferred)
- Strong experience leading global submissions (FDA/EMA/Health Canada)
- Proven success in IND/CTA strategy, clinical development, and lifecycle management
- Ability to influence senior leadership and drive regulatory decisions
- Experience working in fast-paced biotech environments
Why this role is exciting:
This company is advancing high-potential oncology programs with a clear pathway to commercialization, and they’re looking for a strategic leader who can drive regulatory success across the full development lifecycle.
Location: Boston, MA
If you’re a regulatory leader in oncology and interested in hearing more, please reach out or apply directly.