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