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