Executive Director, Regulatory Affairs Lead

4 days ago


Tarrytown, New York, United States Regeneron Pharmaceuticals Full time
Job Summary

This is an exciting opportunity to lead the work of a team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs.

Key Responsibilities
  • Lead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in the area of general medicine with a focus in the area of cardiovascular and metabolic diseases.
  • Develop and implement regulatory strategies for development programs in the assigned Therapeutic Area to ensure Regulatory Agency approval within specified timelines.
  • Manage liaisons and/or provide direction to regulatory representatives to project teams who effect and communicate regulatory strategies.
  • Review critical regulatory communications and evaluate conformance with regulatory requirements, clarity, and completeness.
  • Ensure necessary state of compliance for all regulatory commitments/requirements, including supervising/managing others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, etc.
Requirements
  • Ph.D., PharmD, or MD degree.
  • A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of which should include regulatory experience.
  • Research laboratory, process development, or manufacturing experience with biotechnology products highly desirable.
  • Excellent written and verbal communication skills.
About Regeneron

Regeneron Pharmaceuticals 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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.



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