Regulatory Life Cycle Management Specialist
6 days ago
CK Group is seeking a highly skilled Regulatory Life Cycle Management Scientist to join their team on a contract basis for 12 months.
About the Company
Our client is a global consumer healthcare business with well-known household brands.
Key Responsibilities
- Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
- Coordinate with Local Regulatory Affairs for variations, renewals, and answering health authority requests.
- Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio.
- Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system.
- Ensure that the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
- Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.
Requirements
- Education to Masters' degree level in pharmacy, engineering, chemistry, or a similar field.
- Regulatory affairs experience in OTC medicinal products and experience of lifecycle management across EU or wider markets.
- Experience of dossier maintenance and product change management as well as working with complex Regulatory databases.
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