Manager, Regulatory Affairs Strategy - Oncology
Regeneron
August 11, 2026
Remote friendly (Tarrytown, NY)
United States
Corporate Functions
Discover Your Role
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development (INDs/CTAs, amendments and information requests, orphan drug applications, annual reports, Investigator’s Brochure).
- Assist in coordination and preparation for Agency meetings and associated briefing documents.
- Lead and track queries and commitments with regulatory agencies; collaborate with subject matter experts to provide written responses; provide periodic status updates regarding conditions/commitments.
- Represent study-level regulatory activities; participate in cross-functional departmental projects and product development activities/meetings.
This Role Requires
- Minimum MD, PhD, or PharmD degree with 2+ years of regulatory experience.
- Experience working on filings, developing regulatory-related documents, and engaging with external partners and authorities.
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices.
- Preferred: experience interacting with CROs for ex-US/ex-EU CTAs toward clinical trial activations.
- High attention to detail; ability to coordinate and prioritize assigned projects.
- Strong interpersonal skills, written and verbal.
Application Instructions
- Apply now.
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development (INDs/CTAs, amendments and information requests, orphan drug applications, annual reports, Investigator’s Brochure).
- Assist in coordination and preparation for Agency meetings and associated briefing documents.
- Lead and track queries and commitments with regulatory agencies; collaborate with subject matter experts to provide written responses; provide periodic status updates regarding conditions/commitments.
- Represent study-level regulatory activities; participate in cross-functional departmental projects and product development activities/meetings.
This Role Requires
- Minimum MD, PhD, or PharmD degree with 2+ years of regulatory experience.
- Experience working on filings, developing regulatory-related documents, and engaging with external partners and authorities.
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices.
- Preferred: experience interacting with CROs for ex-US/ex-EU CTAs toward clinical trial activations.
- High attention to detail; ability to coordinate and prioritize assigned projects.
- Strong interpersonal skills, written and verbal.
Application Instructions
- Apply now.