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