Senior Regulatory Compliance Specialist
3 weeks ago
Compensation:
Competitive hourly rate available.
Key Responsibilities:
- Oversee a range of products within designated therapeutic areas for OTC Medicines, Cosmetics, Medical Devices, and/or Food Supplements.
- Formulate regulatory strategies, prepare necessary regulatory submissions, and assist in maintenance activities within the relevant therapeutic domains.
- Compile and prepare regulatory submissions (including Marketing Authorisations and Reclassifications), respond to inquiries from Regulatory Agencies, and manage correspondence in line with EU regulations and guidelines.
- Approve packaging materials, leaflets, SmPCs, and promotional content to ensure compliance with regulatory standards for submissions through internal systems.
- Maintain and renew Marketing Authorisations as required.
- Degree in Life Sciences or Chemistry at the honours level or equivalent.
- Proven experience in planning, executing, and managing regulatory submissions and multiple projects to achieve departmental and organizational goals.
- Ability to identify and develop solutions with technical guidance on a variety of moderate scope and complexity issues.
- Experience with OTC medicines is essential; familiarity with cosmetics, medical devices, and/or food supplements is advantageous but not mandatory.
- Strong project management skills, knowledge of the regulatory landscape, experience interacting with Regulatory Authorities, commercial and strategic awareness, and the ability to implement regulatory strategies while managing and maintaining Marketing Authorisations.
CK Group collaborates with one of the largest and most diversified healthcare companies dedicated to enhancing access and affordability, fostering healthier communities, and promoting a healthy mind, body, and environment for all.
Work Arrangement:
This position offers a hybrid working model with a flexible schedule.
Application Process:
Candidates must possess the right to work in the UK. Please refer to the job reference in all communications.
Note:
This position may require a satisfactory basic Disclosure and Barring Service (DBS) check.
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