CMC Regulatory Affairs Senior Manager Principal Scientist

Job is Expired
Location: Nationwide
Compensation: Salary
Staff Reviewed: Fri, Sep 01, 2023

Job Summary

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

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