Remote Strategy Biologics Chemistry Manufacturing and Controls Regulatory Manager

Location: Nationwide
Compensation: Salary
Staff Reviewed: Wed, Apr 20, 2022
This job expires in: 4 days
Job Summary

A pharmaceutical and biotechnology development company is searching for a person to fill their position for a Remote Strategy Biologics Chemistry Manufacturing and Controls Regulatory Manager.

Core Responsibilities of this position include:

  • Supporting regulatory affairs and subject matter experts in drafting of Module 3 sections
  • Collaborating with biologics process development and analytical operations teams
  • Reviewing draft CMC sections in collaboration with contributors and internal and external stakeholders

Skills and Requirements Include:

  • Minimum of eight years of experience in Regulatory Affairs CMC or other relevant industry experience
  • A Bachelor of Science degree in a related field
  • Able to interpret regulatory requirements and collaborate with biologics development and/or commercial teams
  • Knowledgeable of regulatory requirements for biologics
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