Associate Manager, Regulatory Affairs Strategy - Oncology
Regeneron
August 13, 2026
Remote friendly (Tarrytown, NY)
United States
Corporate Functions
Role: Associate Manager, Regulatory Affairs (Regulatory Affairs Strategy – Oncology)
Responsibilities:
- Coordinate preparation, submission, management, and maintenance of global regulatory submissions for oncology therapeutics (e.g., INDs/CTAs, amendments and information requests, orphan drug applications, annual reports, investigator’s brochure).
- Assist with coordination and preparation for agency meetings and briefing documents.
- Manage and track regulatory agency queries and commitments; collaborate with SMEs on written responses and provide status updates.
- Represent study-level regulatory activities and participate in cross-functional product development activities/meetings.
- Conduct research to support regulatory strategy for the assigned clinical development program.
- Maintain current knowledge of regulatory requirements; comment on draft guidance; communicate regulatory changes.
- Apply discretion and independent judgment in executing duties.
Qualifications/Required:
- Minimum MD, PhD, or PharmD with relevant internship, fellowship, post-doc, or industry experience.
- Knowledge of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry practices.
- Proficient written, oral, and interpersonal communication in English.
Preferred:
- Oncology experience.
- Experience interacting with CROs for ex-US/ex-EU CTAs.
Skills:
- High attention to detail; ability to organize and prioritize.
- Ability to collaborate across the regulatory and broader development organization.
Location: Tarrytown, NY or Warren, NJ (4 days/week on site).
Apply now.
Responsibilities:
- Coordinate preparation, submission, management, and maintenance of global regulatory submissions for oncology therapeutics (e.g., INDs/CTAs, amendments and information requests, orphan drug applications, annual reports, investigator’s brochure).
- Assist with coordination and preparation for agency meetings and briefing documents.
- Manage and track regulatory agency queries and commitments; collaborate with SMEs on written responses and provide status updates.
- Represent study-level regulatory activities and participate in cross-functional product development activities/meetings.
- Conduct research to support regulatory strategy for the assigned clinical development program.
- Maintain current knowledge of regulatory requirements; comment on draft guidance; communicate regulatory changes.
- Apply discretion and independent judgment in executing duties.
Qualifications/Required:
- Minimum MD, PhD, or PharmD with relevant internship, fellowship, post-doc, or industry experience.
- Knowledge of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry practices.
- Proficient written, oral, and interpersonal communication in English.
Preferred:
- Oncology experience.
- Experience interacting with CROs for ex-US/ex-EU CTAs.
Skills:
- High attention to detail; ability to organize and prioritize.
- Ability to collaborate across the regulatory and broader development organization.
Location: Tarrytown, NY or Warren, NJ (4 days/week on site).
Apply now.