Director, Regulatory Affairs Strategy - Cardiovascular/Metabolic
RegeneronNew Jersey, United States • New York, United States
Posted March 4, 2026
205000 - 341600 USD
Full Time
About the Company
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Job Description
The Director Regulatory Affairs Strategy will provide leadership on global regulatory activities for the assigned products. The candidate will supply, lead and/or supervise IND/CTA and BLA submissions activities. A typical day might include providing interpretation of regulatory authorities’ feedback, leading the development of regulatory strategic plans, and working with project teams to resolve complex project issues.
Requirements
- MD, Ph.D., or Pharm D. degree
- Minimum 10 years of pharmaceutical industry experience
- At least 7 years of regulatory experience
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
- High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- Strong interpersonal skills both written and verbally
Benefits
- Comprehensive benefits, including health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave)