Regulatory Affairs Specialist
2 days ago
We are seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team at CK Group, a global Consumer Healthcare company based in Reading. The successful candidate will work on a contract basis for 12 months.
About the RoleAs a Regulatory Life Cycle Management Scientist, you will be responsible for coordinating Regulatory Life Cycle Management activities across multiple countries within and outside Europe. You will work closely with Local Regulatory Affairs teams to ensure compliance with regulations and maintain global master dossiers.
Key responsibilities include:
- Coordinate Regulatory Life Cycle Management activities across multiple countries.
- 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 respective Veeva Quality Tracking system.
- Ensure the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility.
- Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.
To be successful in this role, you will need:
- Educated to ideally 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.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 106651 in all correspondence.
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