Manager, Regulatory Affairs

Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communication with clients and Health Authorities. Support with scientific advice procedures and representation of clients with health authorities. Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client proj...

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