Remote Executive Director, Global Regulatory Affairs

Retained Search

Our client has retained us for a newly created Remote Executive Director, Global Regulatory Affairs position. In this hands-on role, you will develop and deliver innovative global regulatory strategies for product development and approval. The Executive Director of Global Regulatory Affairs will provide strategic direction and guidance on regulatory requirements for assigned gene therapy development programs, driving premarket strategies that lead to robust submissions and timely product approvals.

Position Responsibilities:

• Drive global regulatory affairs strategies and activities across assigned programs.
• Partner closely with cross-functional colleagues to articulate and translate nonclinical and clinical regulatory requirements into practical, strategic regulatory strategies and plans.
• Identify and assess regulatory risks & define strategies to mitigate such risks.
• Plan, write, and review drug applications and submissions, as well as represent Regulatory Affairs with various internal departments to manage activities and coordinate the preparation of regulatory submissions.
• Prepare for and support meetings with regulatory bodies.
• Build and maintain excellent relationships with relevant regulatory agencies.
• Monitor the impact of changing regulations on submission strategies.
• Serve as regulatory subject matter expert throughout the product lifecycle.

Minimum Requirements/Qualifications:

• 15+ years of pharmaceutical/biotechnology industry experience in Regulatory Affairs.
• University degree in life sciences required; advanced degree(s) preferred.
• Experience with rare disease therapeutic products and experience with cell and gene therapy products is highly desirable.
• Experience as lead regulatory representative for development programs required, with sufficient gravitas to lead the development team through regulatory processes.
• Experience and comfort with a fast-paced small biotech company environment.
• Knowledge and experience in interpretation of regulations, guidelines, policy statements, etc.
• Experience in preparing major regulatory submissions and supportive amendments or supplements for early and late-stage development programs.
• Demonstrate excellent leadership and communication skills.
• Demonstrate strong organizatinal and interpersonal skills.

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