CMC Regulatory Expert

4 weeks ago


Bristol, Bristol, United Kingdom RBW Consulting Full time

Job Description: We are seeking a highly skilled Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally.

This contract position involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.

Key Responsibilities:

  • Manage CMC regulatory activities for clinical programs
  • Authoring INDs and IMPDs
  • Responding to Health Authorities
  • Preparing documents for QP release
  • Post-submission management

Key Qualifications:

  • Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products
  • Experience in pre- and post-approval CMC regulatory activities
  • Effective stakeholder management
  • Project management within a CMC context

About RBW Consulting:

RBW Consulting is a leading consulting firm providing expert services in regulatory affairs, quality assurance, and project management.



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