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 projects and actively share with colleagues.
Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise.
Support with VDC strategy implementation and optimization.
Comply with, maintain and contribute to optimizing internal processes.
Support with VDC led commercial, marketing and business development activities including proposal input.
Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.
The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.
Handling of M3 databases
Compilation/handling of wToCs for renewals/variations
Drafting of eAFs and country information letters for dispatch packages
Communication with local affiliates regarding local requirements
Change assessments according to EU variation guideline
CMC background preferred, IT affinity, very detail oriented, excellent communication skills
Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.