Manager Regulatory Affairs Vaccines m/f
Job ID: 16141
Standort: Ingelheim
Unternehmensbereich: Medizin/Zulassung
Boehringer Ingelheim Vetmedica GmbH
We are looking for a dedicated veterinary scientist for our International Regulatory Affairs Europe group, who will strongly contribute the global vaccine portfolio.
The main objective of this position is to achieve and maintain registrations for veterinary vaccines in Europe focussing on safety and efficacy parts.
Your tasks will include:
•    Supervise and prepare registration dossiers, the submission of registration dossiers to Operating Units (OPUs) / licencees / competent authorities, clinical trial applications and documentation for new and existing products including preparation of detailed and critical summaries
•    Supervise and prepare answers to list of questions from OPUs / competent authorities (all dossier parts) and assure consistency of the responses to questions
•    Liaise with EU competent authorities and supervise / maintain contact between and within OPUs / licencees to assist with pre- and post-approval regulatory issues
•    Close co-operation with R&D Vaccines / external experts regarding the design of studies and quality / suitability of study protocols, study reports, detailed and critical summaries and other documentation
•    Evaluate the contents of registration dossiers for regulatory compliance and suitability for registration according to current legislation and requirements
•    Ensure the provision of regulatory advice and registration strategy for existing products
•    Provide support for the Corporate Product Database and guarantee the maintenance of an orderly and standardised filing / archiving system
•    Represent company at internal and external functions (e.g. Industry Associations) and participate in international project teams as global or European core or sub team member
Your qualification:
•    Degree in Life Science (Veterinarian, Biologist) with Ph.D. or comparable degree, preferably in the field of microbiology, virology or vaccine process development
•    Good knowledge of European Regulatory legislation and requirements for the development and maintenance of veterinary vaccines
•    Understanding of development of veterinary vaccines
•    Thoroughness, commitment, attention to details and persistence
•    Ability to work to firm deadlines, in an independent result-orientated manner as well as in a team
•    Good communication, negotiation and organisational skills
•    Excellent written and spoken English (presentations, phone conversation, meetings, correspondence)
We offer a competitive salary accompanied by a full range of benefits.
If you feel qualified and challenged by the opportunity to work in such an environment, please send your 
application with a short description of previous work.
For further detailed information please contact Luc-Etienne Fabry, 
phone +49 (0) 61 32 / 77 37 27.
As a company without barriers, we welcome applications from the severely disabled if they have the relevant qualifications.
Please send your application online - quoting the code 16141.
Boehringer Ingelheim 
Vetmedica GmbH 
Human Resources 
Angela Geibel 
55216 Ingelheim am Rhein 
German