Regulatory Life Cycle Management Scientist
3 weeks ago
Regulatory Life Cycle Management Scientist
CK Group are recruiting for a Regulatory Life Cycle Management Scientist to join a biopharmaceutical company who are based in Reading on a contract basis for 12 months.
Company:
Out client is a global consumer healthcare business with well known household brands.
Location:
The role is based in Reading
Role:
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.Your Background:
Educated to ideally Masters’ degree level in pharmacy, engineering, chemistry or a similar field. Regulatory affairs experience, preferably in consumer health and preferably across multiple regulatory classification areas Experience of dossier maintenance and product change management as well as working with complex Regulatory databases Excellent attention to detail, good communication and presentation skills.-
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