Oncology Regulatory Strategy Associate Manager

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Hybride; USD 109 900 - 179 300; Plein temps

Avantages offerts par ce poste

Annual bonus

Equity awards

Pension plan

401(k) match

Health programs

Fitness centers

Insurance benefits

Paid time off

Family benefits

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) in Tarrytown, NY or Warren, NJ is seeking an Associate Manager in Regulatory Affairs Strategy (Oncology). This hybrid role requires 4 days on site and involves coordinating global regulatory submissions for oncology programs.

You will assist in agency meetings, manage agency queries, prepare briefing documents, and help shape regulatory strategy with cross-functional teams. Strong English communication is essential.

Qualifications

• Minimum Bachelors Degree (Advanced degree strongly preferred).
• 2-3 years of pharmaceutical industry experience in regulatory affairs; oncology preferred.
• Knowledge of US FDA and international guidance, regulations, drug development processes.
• Experience interacting with CROs for ex-US/ex-EU CTAs toward clinical activations preferred.
• High attention to detail and ability to prioritize projects.
• Excellent written and oral English communication.

Responsabilités

• Coordinate preparation, submission, management and maintenance of global regulatory submissions in oncology (INDs/CTAs, amendments, Orphan drug apps, annual reports, Investigator’s Brochure).
• Assist in agency meeting prep and briefing documents.
• Manage queries and commitments with regulatory agencies; provide status updates.
• Represent study-level regulatory activities and participate in cross-functional teams.
• Conduct research to support regulatory strategy for assigned programs.
• Maintain up-to-date regulatory knowledge and communicate changes as needed.
• Exercise discretion and independent judgment in duties.

Description du poste

Regeneron Pharmaceuticals, Inc (USA) in Tarrytown, NY or Warren, NJ is seeking an Associate Manager in Regulatory Affairs Strategy (Oncology). This hybrid role requires 4 days on site and involves coordinating global regulatory submissions for oncology programs.

You will assist in agency meetings, manage agency queries, prepare briefing documents, and help shape regulatory strategy with cross-functional teams. Strong English communication is essential.