Global Regulatory Affairs Coordinator
5 days ago
CK Group is seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team on a contract basis for 12 months.
Company Overview
Our client is a leading global consumer healthcare business with well-established household brands.
Job Summary
We are looking for a talented individual to coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe. The successful candidate will work closely with Local Regulatory Affairs teams to ensure compliance with regulatory requirements.
Key Responsibilities
- Coordinate Regulatory Life Cycle Management activities across multiple countries, ensuring compliance with regulatory requirements.
- Work closely with Local Regulatory Affairs teams to coordinate variations, renewals, and responses to health authority requests.
- Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance.
- Ensure regulatory assessments are conducted for change controls in the Veeva Quality Tracking system.
- Maintain and update the Veeva Regulatory Information Management system for all activities under the role's responsibility.
- Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.
Requirements
- Educated to at least 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.
- Excellent attention to detail, good communication, and presentation skills.
What We Offer
CK Group is a leading recruitment agency in the pharmaceutical and life sciences industry. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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