Manager, Regulatory Affairs Strategy - Oncology

$128.6k - $210k

Regeneron Pharmaceuticals, Inc.

Warren, MI

Responsibilities

Coordinate preparation, submission, and maintenance of global regulatory submissions for INDs, CTAs, and annual reports
Assist coordination and preparation for agency meetings and briefing documents
Lead tracking of regulatory agency queries and commitments with written responses
Provide regulatory representation for study-level activities and cross-functional team participation
Support Global Regulatory Liaison in all regulatory affairs aspects of therapeutics development

Requirements

MD, PhD, or PharmD degree with minimum 2+ years regulatory affairs experience
Experience preparing regulatory filings and developing regulatory documents
Knowledge of US FDA and international pharmaceutical regulations and guidance
Understanding of drug development processes and industry standard practices
Experience managing ex-US/ex-EU CTAs with CROs preferred
Strong written and verbal communication skills
High attention to detail and project prioritization ability

Compensation: $128,600-$210,000 annually

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Vacancy posted 6 days ago

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