Senior Director, Regulatory Affairs

For our client, we are seeking a Senior Director, Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space. This leader will own U.S. regulatory strategy for a portfolio of products and programs, ensuring that development and commercialization plans are aligned with evolving regulatory requirements. The role will partner closely with global leadership, clinical teams, and cross-functional stakeholders to guide filings, manage risk, and support high-stakes FDA interactions. This position calls for deep expertise in drug development regulations, strong business judgment, and the ability to influence outcomes in complex oncology programs. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $211,200 – $281,200 annually Responsibilities Lead development and execution of U.S. regulatory strategies for products and programs Provide authoritative regulatory advice to global leaders and senior management Serve as the primary regulatory leader for FDA engagement and negotiations Oversee preparation and submission of U.S. regulatory filings Ensure regulatory requirements are integrated into clinical development and commercialization plans Manage regulatory risk assessment and critical issue resolution Build partnerships across functions to achieve integrated program objectives Qualifications 15+ years of experience in the pharmaceutical or biotechnology industry with U.S. Regulatory Affairs experience Bachelor's degree in a scientific or health-related discipline; advanced degree preferred Proven leadership in complex U.S. regulatory strategies Direct FDA interaction experience with significant regulatory accomplishments Expert knowledge of U.S. drug development regulations and submission requirementsExperience in early and late-stage oncology preferred Strong strategic and business acumen with effective negotiation skills Benefits Comprehensive medical, dental, and vision coverage 401(k) plan with company match Flexible spending accounts (FSA/HSA) Life insurance and wellness programs Paid time off and employee stock purchase plan Opportunities for discretionary equity awards Commitment to fair and equitable compensation practices Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs. #J-18808-Ljbffr Ladders