
Expert Regulatory CMC
2 days ago
Your Role:
- Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):
- Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as appropriate).
- Active participation in Change Control Process meetings, Chair of Quality Regulatory Assessment Committee (QRAC) meetings and monthly updates sessions, author/co-author of Position Papers and responses to Reg CMC queries, SME for guidelines revision, etc.).
- Ensure alignment between CMC Regulatory Intelligence and GRA CMC & Device teams (e.g., by improving interoperability, agility, engagement and cohesion).
- Deliver, from a non-product specific perspective, on small molecules, large molecules, medical devices (i.e., drug-device combinations) with regards to marketed post-approval activities as per CMC Regulatory Intelligence Road maps.
- Participation in Trade Association calls in listening & learning/observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
- Provide support on digitalization projects.
- Effective utilization of Veeva system for all the CMC regulatory activities.
Who You are:
Education
- Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree). Higher degree preferable (e.g. PhD in a scientific discipline) or education in Regulatory Affairs.
- 10 years of overall work experience (e.g. generated in Pharma environment, Competent authority, Academia, R&D, Consultancy) related and applicable to this CMC Regulatory Intelligence role. Minimum 5 years of Global CMC regulatory experience.
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