Director, Regulatory Affairs Strategy - Genetics Medicine

Build our future together:

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.

When & where:

• Work Location: Tarrytown, NY or Warren, NJ

• 4 days per week on site

Discover your role:

• 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.

• You bring a strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices.

• You have demonstrated success leading regulatory strategy and health authority interactions across global programs, with the ability to influence cross-functional teams and senior leadership.

• You are comfortable operating in ambiguous, fast-paced environments and can manage multiple programs and priorities simultaneously.

• You have experience managing or interacting with CROs in the management of ex-US/ex-EU CTAs toward clinical trial activations.

• You bring strong interpersonal and communication skills, both written and verbal, with the ability to produce persuasive and high-quality regulatory documents.

This role requires:

• 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.

• This role requires onsite presence 4 days per week in Tarrytown, NY or Warren, NJ. Relocation support is available for qualified candidates.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$205,000.00 - $341,600.00