Director, Regulatory Affairs Strategy - Genetics Medicine

About the role

The Director, Regulatory Affairs Strategy will provide leadership on global regulatory activities for assigned products within the Genetic Medicine portfolio. This role is focused on regulatory strategy and filings, with responsibility for providing regulatory leadership across project teams. Consistent with our hands-on culture, the Director will be actively involved in clinical study support and will lead IND/CTA and BLA submission activities.

Responsibilities

• Provide interpretation of regulatory authority feedback, policies, and guidelines, and communicate strategic implications to project teams and senior management.
• Lead the development and maintenance of regulatory strategic plans, either directly in conjunction with project teams or through direct reports. Own the preparation of major clinical submissions required for regulatory approvals.
• Work with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
• Ensure the quality and timeliness of regulatory submissions for IND/CTA/BLA; collaborate with other functions and partners in the preparation, review, and completion of submission documents.
• Represent regulatory affairs at senior program team meetings, providing strategic input and direction as a subject matter expert.
• Plan, prioritize, and oversee regulatory activities in close collaboration with leads from other functions to ensure compliance and alignment with project timelines.
• Mentor and develop regulatory staff, providing direction and supporting career growth.

Requirements

• A strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices.
• Demonstrated success leading regulatory strategy and health authority interactions across global programs, with the ability to influence cross-functional teams and senior leadership.
• Comfortable operating in ambiguous, fast-paced environments and managing multiple programs and priorities simultaneously.
• Experience managing or interacting with CROs in the management of ex-US/ex-EU CTAs toward clinical trial activations.
• Strong interpersonal and communication skills, both written and verbal, with the ability to produce persuasive and high-quality regulatory documents.

Qualifications

• An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred.
• A minimum of 10 years of pharmaceutical or biotechnology industry experience, with at least 7 years in regulatory affairs, including direct experience as a regulatory liaison.