Regulatory CMC 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