CMC Regulatory Affairs Senior Manager Principal Scientist

Company: VirtualVocations
Location: Jamaica
Posted on: September 21, 2023

Job Description:

A company is looking for a CMC Regulatory Affairs Senior Manager Principal Scientist.
Key Responsibilities:

Participate in the development and execution of Regulatory CMC strategies for gene therapy programs
Generate CMC-related regulatory documentation and submissions in compliance with regulations
Assess and communicate CMC regulatory requirements and provide guidance on compliance

Required Qualifications:

Bachelors or Masters Degree in life science field or related scientific discipline
3+ years of experience in Regulatory CMC or related field
Experience with regulatory submissions and viral vector gene therapy products preferred
Prior successful filing of IND/CTA and/or BLA/NDA/MAA preferred
Working knowledge of FDA, EMA, and ICH regulations/guidance

Keywords: VirtualVocations, Hempstead , CMC Regulatory Affairs Senior Manager Principal Scientist, Executive , Jamaica, New York

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