Life Cycle Management Professional
7 days ago
Job Title: Regulatory Life Cycle Management Scientist
Company: CK Group
Job Type: Contract
Location: Remote (with occasional travel to Reading)
Job Description:
We are seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team on a 12-month contract basis. As a key member of our global Consumer Healthcare company, you will play a critical role in coordinating Regulatory Life Cycle Management activities across multiple countries.
Key Responsibilities:
- Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
- Collaborate with Local Regulatory Affairs teams for variations, renewals, and responding to 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 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 labeling and approval to enable commercial activation of product launches.
Requirements:
- Educated to a minimum of a Master's 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 specializing in the placement of professionals in the pharmaceutical and life sciences industries. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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