Senior Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement comprehensive U.S. regulatory strategies for designated products and programs throughout clinical development, registration, post-approval obligations, and lifecycle management.

• Provide expert U.S. regulatory guidance to global regulatory leaders, development teams, governance committees, and senior management.

• Evaluate strategic options, risks, trade-offs, and mitigation plans, integrating U.S. regulatory considerations into global strategies.

• Act as the primary regulatory authority for FDA interactions, overseeing planning, leading, and negotiating both formal and informal engagements.

• Supervise the strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings.

• Integrate U.S. regulatory requirements and FDA expectations into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions.

• Lead regulatory risk assessment and critical issue management, escalating significant risks and fostering cross-functional alignment on mitigation and execution.

• Maintain in-depth knowledge of FDA regulations, guidance, policy developments, and precedents while evaluating portfolio implications.

• Cultivate partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other departments.

• Represent Regulatory Affairs on senior cross-functional teams and governance forums, effectively communicating complex regulatory issues to stakeholders.

• Anticipate high-impact regulatory risks related to the portfolio or programs, directing mitigation, escalation, and risk-acceptance decisions.

• Influence regulatory practices, operational approaches, innovation, future organizational capabilities, procedures, and process enhancements.

• Recruit, develop, mentor, and retain regulatory talent; set priorities and performance expectations.

• Provide direct and matrixed supervision, capability building, succession planning, performance management, and development of a high-performing U.S. regulatory team.

• Represent the organization in external industry forums and regulatory policy discussions as necessary.

⛳️ Requirements

• Over 15 years of experience in the pharmaceutical or biotechnology sector, with extensive progressive experience in U.S. Regulatory Affairs and leadership of complex development programs.

• A Bachelor’s degree in a scientific or health-related field is required.

• An advanced scientific, medical, pharmacy, or regulatory degree is preferred.

• Proven leadership in developing complex U.S. regulatory strategies across multiple programs.

• Experience in both early- and late-stage oncology is preferred.

• Demonstrated success as a U.S. regulatory lead with direct FDA interaction experience and significant regulatory achievements in development, registration, and lifecycle management.

• Expert knowledge of U.S. drug development regulations, guidance, policy trends, and submission requirements, including INDs, NDAs, and/or BLAs.

• Experience with expedited development programs is preferred.

• Proven experience in creating and executing integrated regulatory strategies for complex programs.

• Oncology experience, as well as familiarity with both small-molecule and biologic products, is preferred when relevant to the portfolio.

• Demonstrated capability to lead critical FDA interactions, negotiate effectively, resolve ambiguous or precedent-setting issues, and convey clear recommendations to senior leaders.

• Strong strategic and business acumen.

• Ability to balance patient, scientific, regulatory, operational, and commercial factors and make informed decisions under uncertainty.

• Documented success in leading cross-functional teams, influencing without authority, and fostering alignment among global and U.S. stakeholders.

• Proven leadership skills, including recruitment, coaching, performance management, organizational development, and nurturing future regulatory leaders.

• Excellent written and verbal communication abilities.

• Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills.

• Proficiency with the Microsoft Office suite.

• Experience with Veeva regulatory publishing.

• Skills in PowerPoint presentation creation and delivery.

• Willingness to travel for business purposes 10–20% as required.

🏝️ Benefits

• Eligibility for annual bonus plans for non-commercial roles.

• Eligibility for incentive compensation plans for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Commitment to equal opportunity employment and support for reasonable accommodations.