Senior Director Regulatory Affairs
About the Opportunity
Clinical-stage biopharmaceutical company advancing innovative therapies in oncology. Lead program is in late-stage development, and we are seeking an experienced regulatory leader to drive global strategy and major submissions. This is a high-impact role with visibility across executive leadership and cross-functional teams.
Key Responsibilities
- Lead global regulatory strategy for clinical development and life-cycle management of oncology programs.
- Oversee preparation and submission of regulatory filings, including INDs, CTAs, NDAs, MAAs, briefing documents, and related materials.
- Serve as the regulatory subject matter expert on cross-functional teams and provide strategic input to senior leadership.
- Manage interactions with global health authorities, including leading negotiations and ensuring alignment with regulatory expectations.
- Identify regulatory risks and implement mitigation strategies to support program success.
- Build and mentor a regulatory team, establish processes, and implement systems to support compliance and efficiency.
Qualifications
- Education: Bachelor's degree in a scientific discipline required; advanced degree (PharmD, PhD, MS) preferred.
- Experience:
- 12+ years in Regulatory Affairs within pharma/biotech.
- Proven track record of leading major submissions (NDA, MAA) and global regulatory strategies.
- Strong oncology experience required.
- Skills: Strategic thinker with excellent leadership, communication, and cross-functional collaboration abilities.
Why Join Us?
- Opportunity to shape regulatory strategy for a late-stage oncology program.
- Collaborative, mission-driven environment focused on delivering transformative therapies to patients.
- Competitive compensation and benefits package.
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