Regulatory CMC Project Manager

​Regulatory CMC Project Manager - Contract

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