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Regulatory CMC Project Manager

Employer
RBW Consulting
Location
London
Salary
Competitive
Closing date
19 Nov 2024
View more categoriesView less categories
Sector
Healthcare
Contract Type
Contract / Freelance
Hours
Full Time
Job Function
Project Manager

Regulatory CMC Project Manager - Contract

Heavily remote - some travel required.

Partnering with an international pharmaceutical company focused on both in house product development and CDMO services, we are now supporting the appointment of a new Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally.

This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period.

This role 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:

  • Change control procedures
  • Out of specification management
  • CMC commitments and variation submissions
  • Product Quality Review (PQR) production and review
  • Collaboration with external CMOs
  • Manage CMC regulatory activities for clinical programs, including:
  • Authoring INDs and IMPDs
  • Responding to Health Authorities
  • Preparing documents for QP release
  • Post-submission management

Key Experience:

  • 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
  • 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
  • Language skills: Proficient in English, French is an advantage

Regulatory, CMC, project, manager, small, molecule, IND, IMPD, PQR, change, control, quality, assurance, RA, affairs, submission, oncology, cancer, therapy, MAA, marketing, authorisation

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