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