Regulatory Affairs CMC Project Manager
Company Summary:
My client, a global leading biotechnology company focused on fighting a wide range of rare diseases is looking to add a Regulatory CMC professional to their team! This role will be hybrid based in Portsmouth, New Hampshire requiring 2 days per week onsite.
The Regulatory Affairs CMC Project Manager will be responsible for:
- Leading the submission preparation and reviewing customer clinical (IMPD/INDs) and commercial (MAA/BLAs) filings
- Preparing and/or reviewing of scientific and technical information for Health Authority submission in accordance with applicable Lonza procedures
- Supporting for scientific advice meetings and development of regulatory strategy
- Interpreting of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of products and maintaining transparency of information across regulatory function
- Support site-specific regulatory documentation and activities
The Regulatory Affairs CMC Project Manager should have the following qualifications:
- Bachelor's degree with 5+ years of experience working in the pharmaceutical/biotechnology industry
- 5+ years of experience preparing and authoring CMC DS sections for IMPD, IND, BLA
- Project management and computer software skills
- Regulatory Affairs Certification (RAC) is preferred
