Oncology Regulatory Strategy Manager

Regeneron; New Jersey; Hybrid; USD 128,600 - 210,000; Full time

Job summary

Regeneron is seeking a Manager in Regulatory Affairs Strategy Oncology to support global regulatory submissions and agency interactions. This role reports to the Global Regulatory Liaison and focuses on clinical and nonclinical development, with on-site work in Tarrytown, NY or Warren, NJ in a hybrid arrangement.

You will coordinate INDs/CTAs and related documents, prepare briefing materials for Agency meetings, and manage responses to inquiries while collaborating with subject matter experts

Qualifications

• Minimum MD, PhD or PharmD with 2+ years regulatory experience.
• Experience filings and preparing regulatory documents.
• Familiarity with US FDA and international pharmaceutical guidance.

Responsibilities

• Coordinate global regulatory submissions (INDs/CTAs, amendments, annual reports, ICB).
• Assist with agency meetings and briefing documents.
• Lead queries and commitments with regulatory authorities and track status.
• Represent study-level regulatory activities in cross-functional teams.

Skills

Regulatory knowledge

Attention to detail

Interpersonal skills

Cross-functional collaboration

Education

MD/PhD/PharmD

Job description

Regeneron is seeking a Manager in Regulatory Affairs Strategy Oncology to support global regulatory submissions and agency interactions. This role reports to the Global Regulatory Liaison and focuses on clinical and nonclinical development, with on-site work in Tarrytown, NY or Warren, NJ in a hybrid arrangement.

You will coordinate INDs/CTAs and related documents, prepare briefing materials for Agency meetings, and manage responses to inquiries while collaborating with subject matter experts