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Senior Regulatory Affairs Manager

Dodane na: Praca: Inne w Niemcy
Ostatnio zaktualizowany: 03/07/09

My client, one of the top leading pharmaceutical companies in the world is currently looking for a Senior Regulatory Affairs Manager (veterinary medicinal products)to take responsibility worldwide for the safety and efficacy dossier within registered pharmaceutical veterinary medicinal products and products in a development stage.
Your tasks will be:
Responsibility for preparation and submission of pre-approval and of post-approval registration dossiers / documentation for pharmaceutical VMPs
Definition, evaluation and interpretation of regulatory requirements for the development of VMPs and dossier assessment
Development and realisation of registration strategies for new and registered products
Responsibility for the technical content of international Summary of Product Characteristics (SPC) for new and registered products
Responsibility to manage, coach, develop and motivate staff
Participation in departmental projects and representation of the company at internal and external functions (e.g. IFAH)
Requirements:
Degree in Life Science (Veterinarian with Ph.D. or equivalent background)
Experience in International Regulatory Affairs for ca. 5 years
Proven extensive experience in European Regulatory Affairs
Established understanding of pharmaceutical drug development
Ability to work to firm deadlines, in an independent result-orientated manner as well as in a team
Fine attention to details
Excellent written and spoken English
Sound knowledge of the MS Office Programs
My client is based near Frankfurt. This is a permanent role and candidates from the whole of Europe are welcome to apply. German language is not essential.
SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business

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