Director, Regulatory Affairs

Job Description

Job Summary:

• Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements.
• Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration.

Duties and Responsibilities:

• Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines.
• Provide hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including NDA/BLA readiness where applicable.
• Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatory commitments.
• Advise internal stakeholders on evolving regulatory requirements and risk mitigation strategies.
• Support preparation, review, and delivery of high-quality regulatory documents and submissions.
• Act as key liaison with clinical, CMC, and executive teams in a high-pressure, fast-moving biotech setting.

Qualifications:

• Extensive Regulatory Affairs experience (typically 12–15+ years) in biotech/pharma.
• Proven experience leading global regulatory strategy for Phase III clinical programs.
• Vaccine experience strongly preferred.
• Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus.
• Demonstrated ability to operate effectively in fast-paced, high-pressure environments.
• Strong leadership, communication, and stakeholder management skills.