Global Regulatory Specialist
1 week ago
Job Title: Global Regulatory Specialist
About the Company:
CV Library is a leading provider of career opportunities in the pharmaceutical industry. We are committed to delivering high-quality services to our clients and candidates.
About the Role:
We are seeking a highly skilled Global Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing CMC regulatory activities for a small molecule oncology product globally. This is a contract position until the end of March 2025, with a strong likelihood of extension for a further 6-month period.
The successful candidate will have over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products. They will also have experience in pre- and post-approval CMC regulatory activities, effective stakeholder management, project management within a CMC context, and knowledge of IND/NDA and IMPD/MAA formats.
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
- 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
- Skills: Proficient in English, French is an advantage
- Opportunity to work on a global project
- Chance to develop skills in CMC regulatory activities
- Professional growth opportunities
- Competitive salary
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