RBW Consulting
Regulatory CMC Project Manager
Job Location
Job Description
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
Location: UK, GB
Posted Date: 12/22/2024
Contact Information
Contact | Human Resources RBW Consulting |
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