Director, Regulatory Affairs Strategy (Genetics Medicine)

Location: Tarrytown, New York or Warren, New Jersey, United States; onsite 4 days per week. Relocation support is available for qualified candidates.

Salary: $205,000–$341,600 annually

Company

Regeneron develops medicines for serious diseases through science and innovation, with a focus on genetic medicine programs.

What you will do

• Lead global regulatory strategy for assigned products across study, indication, and program levels.
• Develop and maintain regulatory strategic plans and lead major clinical submissions, including IND, CTA, and BLA filings.
• Interpret health authority feedback, policies, and guidelines, and communicate strategic implications to project teams and senior management.
• Lead interactions with global health authorities, including briefing book and meeting-slide preparation.
• Represent regulatory affairs in senior program meetings and resolve complex regulatory issues with cross-functional teams and CRO partners.
• Mentor and develop regulatory staff while overseeing activities, quality, compliance, and submission timelines.

Requirements

• MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred.
• At least 10 years of pharmaceutical or biotechnology industry experience, including 7 or more years in regulatory affairs.
• Direct experience as a regulatory liaison and demonstrated success leading global regulatory strategy and health authority interactions.
• Strong knowledge of US FDA and international pharmaceutical regulations, guidance, drug development processes, and industry practices.
• Experience managing or working with CROs on ex-US/ex-EU CTAs through clinical trial activation.
• Onsite presence 4 days per week in Tarrytown, NY or Warren, NJ is required.

Culture & Benefits

• Work in a hands-on, science-driven environment focused on medicines for patients with serious diseases.
• Relocation support is available for qualified candidates.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are provided during recruitment when required.