Lead Regulatory Affairs Strategist
4 weeks ago
CK Group is seeking a Regulatory Affairs Lead to join a prominent organization in the Pharmaceutical sector on a contractual basis.
Hourly Compensation: Up to £62.93 PAYE (inside IR35).
Key Responsibilities:
Oversee a designated product line or specific products within a therapeutic domain, including OTC Medicines, Cosmetics, Medical Devices, and/or Food Supplements.
Formulate regulatory strategies, prepare regulatory submissions, and assist in maintenance activities pertinent to the relevant therapeutic area.
Compile and prepare regulatory documentation (including Marketing Authorisations and Reclassifications), respond to inquiries from Regulatory Agencies, and manage correspondence in compliance with EU regulations and guidelines.
Authorize packaging materials, informational leaflets, Summary of Product Characteristics (SmPCs), and promotional content as necessary to ensure regulatory adherence for submissions through the appropriate internal systems.
Qualifications:
A degree in life sciences or chemistry at the honors level or equivalent is required.
Demonstrated experience in planning, executing, and managing regulatory submissions and multiple projects to achieve departmental and organizational goals.
Experience in cosmetics, medical devices, and/or food supplements is advantageous but not mandatory.
Skills:
Project management expertise, a solid understanding of the regulatory landscape, effective interaction with Regulatory Authorities, commercial and strategic insight, implementation of regulatory strategies, and management of Marketing Authorisations.
About the Company:
Our client is a leading and diversified healthcare organization committed to enhancing access and affordability, fostering healthier communities, and promoting a balanced mind, body, and environment for individuals everywhere.
This position offers a hybrid working model, requiring 1-2 days per week at the client's site.
Please reference the job title in all communications.
This role may require a satisfactory basic Disclosure and Barring Service (DBS) check.
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