Job Description

The Senior Director / Interim Head of Regulatory Affairs provides strategic and operational leadership for global regulatory activities supporting late-stage clinical development programs, with a strong emphasis on Phase III vaccine programs. This role serves as the primary regulatory lead in a fast-paced biotech environment, ensuring alignment with global regulatory requirements and driving programs toward potential registration. The individual will partner cross-functionally with clinical development, CMC, quality, and executive leadership to develop and execute regulatory strategies, manage health authority interactions, and ensure successful preparation for NDA/BLA submissions. Key Responsibilities Regulatory Strategy & Leadership Lead the development and execution of global regulatory strategies for Phase III clinical programs, particularly in vaccines Provide strategic direction to ensure alignment with requirements from major health authorities such as the FDA and EMA Anticipate regulatory risks and develop mitigation strategies to support timely program progression Serve as the primary regulatory advisor to senior leadership and cross-functional teams Health Authority Interactions Act as the main point of contact for regulatory agencies (e.g., FDA, EMA, and other global authorities) Lead preparation and management of key regulatory interactions, including: End-of-Phase II/III meetings Pre-NDA/BLA meetings Scientific advice and advisory committee engagements Ensure consistent, clear, and strategic communication with regulators Regulatory Submissions & Execution Oversee preparation, review, and submission of high-quality regulatory documents, including: IND amendments CTAs NDA/BLA modules (where applicable) Ensure readiness for NDA/BLA submission, including gap assessments and submission planning Provide hands-on leadership in document authoring and review when required Interim Leadership & Program Continuity Serve as Interim Head of Regulatory Affairs, ensuring continuity across ongoing programs Maintain oversight of regulatory commitments, timelines, and deliverables Guide and mentor regulatory team members and consultants Cross-Functional Collaboration Partner closely with: Clinical Development (trial design, endpoints, protocols) CMC (manufacturing and quality documentation) Safety/Pharmacovigilance Commercial and Market Access teams Ensure regulatory strategy is integrated into overall product development plans Compliance & Intelligence Monitor evolving global regulatory requirements and industry trends, particularly in vaccines Provide guidance on regulatory policy changes and their impact on development programs Ensure compliance with applicable regulations and internal quality standards Qualifications & Experience Education Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (PhD, MD, PharmD preferred) Experience 12–15+ years of Regulatory Affairs experience in biotech or pharmaceutical industry Proven track record leading global regulatory strategy for Phase III clinical programs Strong experience in vaccines or infectious disease programs (highly preferred) Hands-on experience with NDA/BLA submissions and/or late-stage regulatory interactions Prior experience in a small or mid-sized biotech environment is advantageous Core Competencies Strategic Thinking: Ability to design and execute complex global regulatory strategies Leadership: Demonstrated ability to lead teams and influence without authority Communication: Excellent written and verbal communication skills, including regulatory writing Stakeholder Management: Strong ability to collaborate across functions and with senior leadership Execution Under Pressure: Proven ability to thrive in fast-paced, high-pressure environments

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