Oncology Regulatory Strategy Manager

BioSpace; New Jersey; On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron seeks a Manager to join the Regulatory Affairs Strategy Oncology team. You will support global regulatory submissions, coordinate with external partners, and help shape regulatory strategies for novel therapeutics across development stages.

Based on-site in NY or NJ, you will work closely with the GRL and cross-functional teams. The role requires an MD/PhD/PharmD and 2+ years regulatory experience, strong FDA knowledge, excellent communication, and the ability to manage multiple

Qualifications

• MD, PhD or PharmD degree with 2+ years regulatory experience.
• Experience with filings and regulatory documents.
• Familiarity with US FDA and international guidelines.

Responsibilities

• Coordinate preparation and submission of global regulatory submissions.
• Prepare for Agency meetings and briefing documents.
• Track agency queries, provide written responses, and monitor commitments.
• Represent study-level regulatory activities in cross-functional teams.

Skills

Regulatory strategy

FDA knowledge

CRO coordination

Project management

Communication skills

Education

MD/PhD/PharmD

Job description

Regeneron seeks a Manager to join the Regulatory Affairs Strategy Oncology team. You will support global regulatory submissions, coordinate with external partners, and help shape regulatory strategies for novel therapeutics across development stages.

Based on-site in NY or NJ, you will work closely with the GRL and cross-functional teams. The role requires an MD/PhD/PharmD and 2+ years regulatory experience, strong FDA knowledge, excellent communication, and the ability to manage multiple