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.