Senior Director Regulatory Affairs
Vivid Resourcing, Boston, MA, United States
Senior Director, Regulatory Affairs – Oncology
Company Overview
A well-funded clinical-stage biopharmaceutical company advancing innovative oncology therapeutics is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy across its expanding oncology pipeline.
The organization is progressing multiple targeted oncology assets through mid- to late-stage development and is entering a critical phase as programs advance toward registration and commercialization.
The Role
The Senior Director will serve as the Global Regulatory Lead for key oncology programs, driving regulatory strategy across the full drug development lifecycle and acting as a strategic partner to executive leadership.
This role offers significant ownership, visibility, and influence over global development decisions within a highly collaborative biotech environment.
Key Responsibilities
- Lead global regulatory strategy for oncology development programs from IND through NDA/BLA
- Serve as Regulatory Lead on cross-functional program teams
- Drive regulatory pathways including expedited programs (Fast Track, Breakthrough Therapy, Priority Review)
- Lead FDA and global Health Authority interactions and meeting strategy
- Oversee preparation of regulatory submissions, briefing documents, and agency responses
- Provide strategic regulatory guidance across clinical development and program planning
- Identify regulatory risks and develop mitigation strategies
- Support global filing and commercialization planning
- Mentor and develop Regulatory Affairs staff
Qualifications
- 12+ years of Regulatory Affairs experience within biotech or pharmaceutical industry
- Strong background in oncology drug development
- Proven experience leading FDA interactions and global submissions
- Deep understanding of global regulatory requirements across the development lifecycle
- Demonstrated leadership within matrixed, cross-functional teams
Why Join
- High-impact leadership role within an oncology-focused biotech
- Direct influence on global development and approval strategy
- Executive visibility and career progression opportunity