Regulatory Affairs Consultant Job at Redbock - an NES Fircroft company, Waltham, MA

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  • Redbock - an NES Fircroft company
  • Waltham, MA

Job Description

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

Job Tags

Remote job,

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