Regeneron is a biotechnology company that discovers, develops, and commercializes medicines for serious and underserved conditions. Its research spans allergy, cardiovascular and metabolic disease, neuroscience, oncology, hematology, ophthalmology, and rare diseases. By combining biological research with advanced technology, Regeneron works on biologics and genetic medicines designed to address complex healthcare needs. The company also highlights health equity, environmental responsibility, scientific education, and ethical corporate practices as part of its broader mission to advance patient care.
Associate Director, Regulatory Affairs Strategy – Genetics Medicine (Hybrid)
Lead regulatory strategy for Regeneron’s pharmaceutical and genetics medicine programs, including FDA engagement, submissions, and global compliance. Coordinate multidisciplinary teams and guide development activities across the product lifecycle.
United States
New Jersey
New York$176,100 – $287,300 / year
HybridFull-timeSeniorEnglish RequiredComplianceDescription
- Shape regulatory strategies for assigned programs with senior leadership.
- Evaluate regulatory guidance and comparable development programs to support approvals and development plans.
- Serve as a liaison with the FDA and other health authorities.
- Oversee regulatory activities across drug development programs.
- Contribute regulatory expertise to multidisciplinary project teams.
- Advise teams on clinical development requirements and manage IND or CTA filings.
- Direct regulatory filings for assigned programs.
- Interpret clinical, preclinical, and manufacturing data and develop evidence-based conclusions.
- Review clinical protocols and clinical and preclinical study reports.
- Lead regulatory communications, including briefing package preparation.
- Verify the completeness and accuracy of regulatory submissions.
- Supervise staff responsible for preparing and submitting regulatory documents.
- Coordinate the planning, preparation, and submission of licensing applications.
- Advise teams on BLA and MAA content, structure, style, format, and timing.
- Support scientific writing and application reviews.
- Track timelines and budgets while reporting progress to senior management.
- Monitor FDA and international regulatory guidance.
- Train scientific staff on applicable regulatory requirements.
Requirements
- Advanced degree such as an MD, Ph.D., Pharm.D., or equivalent; a relevant scientific field is strongly preferred.
- At least 10 years of experience in the pharmaceutical industry.
- At least 5 years of regulatory affairs experience.
- Experience in research laboratories, process development, or biotechnology product manufacturing is highly desirable.
- Strong written and verbal communication abilities.
- Availability to work onsite four days per week.
- Willingness to travel up to 25% as needed.
Benefits
- Annual bonuses and other incentive opportunities.
- Equity award programs.
- Pension or retirement benefits.
- Company matching contributions to a 401(k) plan.
- Health and wellness initiatives.
- Access to fitness centers.
- Medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support programs.
- Reasonable recruitment-process accommodations where required.