Global CMC Compliance Specialist

3 days ago


Glasgow, Glasgow City, United Kingdom RBW Consulting Full time

In this exciting opportunity as a Global CMC Compliance Specialist at RBW Consulting, you will be responsible for overseeing regulatory activities for small molecule oncology products globally. You will manage CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews.

Key responsibilities include:

  • Managing CMC regulatory activities for clinical programs
  • Authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release documents
  • Collaborating with external CMOs and managing post-submission activities

The estimated annual salary for this role is $140,000 - $200,000, based on your qualifications and experience. A degree in Pharmacy or a relevant science/technical subject and proficiency in English are required, with French being an advantage.



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