Regulatory CMC Project Leader
7 days ago
We are seeking a skilled Regulatory CMC Project Manager to join our team at RBW Consulting.
The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product globally.
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:
- Implementing change control procedures
- Managing out of specification assessments
- Coordinating CMC commitments and variation submissions
- Producing and Reviewing Product Quality Reviews (PQRs)
- Collaborating with external Contract Manufacturing Organizations (CMOs)
- Managing CMC regulatory activities for clinical programs, including:
- Authoring Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) documents
- Responding to Health Authorities
- Preparing documents for Qualified Person (QP) release
- Post-submission management
Key Qualifications:
- Over 10 years of experience 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
This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period.
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