Director, Regulatory Affairs; FTE

The company is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for assigned development programs as they advance through late-stage clinical development and toward potential registration. The Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and product lifecycle management. The ideal candidate will bring a balanced combination of strategic regulatory expertise, hands‑on execution, and experience navigating the regulatory requirements of a dynamic biotechnology environment.

• Develop, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs.
• Serve as the Regulatory Affairs representative on cross-functional project teams, providing proactive regulatory guidance to support program objectives and development milestones.
• Evaluate evolving regulatory requirements, competitive developments, and emerging industry trends to assess potential impacts on development plans and regulatory strategy.
• Identify regulatory risks, develop mitigation strategies, and communicate recommendations to project teams and senior leadership.
• Contribute to integrated regulatory and development plans supporting progression from clinical development through commercialization.
• Collaborate with senior regulatory leadership on strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA/NDA planning, and labeling activities.
• Lead the planning, preparation, review, and submission of regulatory documentation throughout the product lifecycle.
• Provide hands‑on leadership for U.S. And international regulatory submissions, including INDs, CTAs, protocol amendments, information amendments, DSURs, annual reports, and labeling documentation.
• Ensure regulatory submissions are accurate, compliant, strategically aligned, and delivered within established timelines.
• Independently manage routine regulatory submissions and maintenance activities while supporting complex registration‑related activities in collaboration with senior regulatory leadership.
• Support the preparation and maintenance of future NDA/BLA and ex‑U.S. Marketing authorization applications.
• Serve as a key regulatory contact for the FDA and support interactions with other international health authorities.
• Lead the preparation of regulatory briefing packages, meeting requests, information packages, and responses to health authority inquiries.
• Participate in and support regulatory authority meetings, teleconferences, and written communications.
• Monitor regulatory intelligence and communicate evolving agency expectations and regulatory precedents to relevant project teams.
• Manage external regulatory consultants and CRO partners supporting global CTA submissions, regulatory maintenance, and health authority responses.
• Drive cross‑functional accountability and alignment to meet critical development milestones and regulatory timelines.

• Participate in departmental initiatives, task forces, and special projects.
• Support due diligence activities, regulatory assessments, and related business initiatives as needed.
• Perform other duties as assigned.

Bachelor's degree in a scientific discipline required. Advanced degree (MS, PharmD, PhD, or equivalent) preferred. 10 15 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry. Experience with in a small or emerging biotechnology company preferred,…