What are the responsibilities and job description for the Regulatory Affairs Consultant position at Redbock - an NES Fircroft company?
Regulatory CMC Consultant
(remote, part-time)
A fast-growing Biotechnology company is in need of a part-time (~20 hours/week) Regulatory CMC Consultant for a 6-month project (potential to extend to 12 months) that can be completed while working remotely. The client is focused on developing monoclonal antibody therapies for conditions like IBD, ulcerative colitis, and Crohn's disease.
The consultant will be focused on:
- hands-on development and maintenance of change control assessments for stability and shelf-life extensions.
- supporting change control and shelf-life extension submissions to multiple regions in complex ongoing studies.
- working with Clinical Supply and Quality teams to manage a shelf-life extension tracker and also support drug release to clinics
Top Requirements:
- BS degree minimum
- Strong communication skills to be successful while working remotely with cross-functional teams
- 5-10 years of experience as a Regulatory CMC expert
- Experience with biologics, not small molecule or vaccines
- Strong hands-on independent experience developing change control assessments for shelf-life extensions and manufacturing processes
Bonus Experience:
- direct experience supporting monoclonal antibodies therapy
- direct experience developing global regulatory filings
- Supply Chain, Manufacturing, or Lab experience to help understand complexities regarding shelf-life
