Regulatory CMC Product Lead

2 days ago


Glasgow, Glasgow City, United Kingdom RBW Consulting Full time
Key Position Summary

The Regulatory CMC Product Lead will be responsible for managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews. This contract position involves collaborating with external CMOs and managing post-submission activities.

Main Responsibilities:
  • Manage CMC regulatory activities for clinical programs, including authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release documents.
  • Collaborate with external CMOs and manage post-submission activities.
Requirements:
  • Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products.
  • Pre- and post-approval CMC regulatory activities experience.
  • Effective stakeholder management, project management within a CMC context.
  • Knowledge of IND/NDA and IMPD/MAA formats, understanding of drug substance and product CMC.
  • Organized, independent, and able to manage multiple activities.
  • Degree in Pharmacy or a relevant science/technical subject, proficient in English, French is an advantage.
Compensation Package: $100,000 - $130,000 per year

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