Associate Manager, Regulatory Affairs Strategy - Oncology

$109.9k - $179.3k

Regeneron Pharmaceuticals, Inc.

Warren, MI

Responsibilities

Coordinate preparation, submission, and management of global regulatory filings including INDs, CTAs, and annual reports
Assist with Agency meeting coordination and briefing document preparation
Track regulatory agency queries and commitments, collaborate with experts on written responses
Support study-level regulatory activities and cross-functional product development meetings
Research and develop regulatory strategy for assigned clinical development programs

Requirements

MD, PhD, or PharmD degree with relevant internship, fellowship, post-doc, or industry experience
Oncology experience preferred
Knowledge of US FDA and international pharmaceutical guidance and drug development regulations
Experience with CRO management for ex-US/ex-EU clinical trial activations preferred
Strong attention to detail and project prioritization skills
Excellent written, oral, and interpersonal communication abilities in English

Compensation: $109,900-$179,300 annual

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Vacancy posted 6 days ago

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