Oncology Regulatory Affairs Strategy Manager – Hybrid

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive total rewards package

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager to join the Regulatory Affairs Strategy Oncology team.

You will coordinate preparation, submission, and maintenance of global regulatory submissions and assist in agency meetings and briefing documents. This role requires an MD, PhD, or PharmD with 2+ years of regulatory experience, experience with US FDA and international guidelines, and strong written and verbal communication.

Qualifications

• MD/PhD/PharmD with 2+ years regulatory experience.
• Experience with filings and preparing regulatory documents.
• Knowledge of US FDA and international guidance and drug development process.

Responsibilities

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions (INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, Investigator’s Brochures).
• Assist in coordination and preparation for agency meetings and briefing documents.
• Lead and track queries and commitments with regulatory agencies, providing written responses and status updates.
• Represent study-level regulatory activities and participate in cross-functional projects/meetings.

Skills

Regulatory affairs experience

FDA/regulatory guidelines

Communication skills

Education

MD/PhD/PharmD

Job description

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager to join the Regulatory Affairs Strategy Oncology team.

You will coordinate preparation, submission, and maintenance of global regulatory submissions and assist in agency meetings and briefing documents. This role requires an MD, PhD, or PharmD with 2+ years of regulatory experience, experience with US FDA and international guidelines, and strong written and verbal communication.