Director, Regulatory Affairs Strategy - Genetics Medicine

Regeneron Pharmaceuticals•Warren, MI

3d•Hybrid

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Regulatory Affairs Strategy team. 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. The Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. This role also carries people management responsibility, including mentoring and developing regulatory staff. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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 can manage 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.
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.

Responsibilities

Providing interpretation of regulatory authority feedback, policies, and guidelines, and communicating strategic implications to project teams and senior management.
Leading the development and maintenance of regulatory strategic plans, either directly in conjunction with project teams or through direct reports.
Owning the preparation of major clinical submissions required for regulatory approvals.
Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
Ensuring the quality and timeliness of regulatory submissions for IND/CTA/BLA; collaborating with other functions and partners in the preparation, review, and completion of submission documents.
Leading health authority interactions, including preparation of briefing books and meeting slides, and advising relevant stakeholders on agency feedback.
Representing regulatory affairs at senior program team meetings, providing strategic input and direction as a subject matter expert.
Planning, prioritizing, and overseeing regulatory activities in close collaboration with leads from other functions to ensure compliance and alignment with project timelines.
Mentoring and developing regulatory staff, providing direction and supporting career growth.