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