Regulatory Affairs Manager (m/f)

-Responsibility for the preparation of pre-approval and post-approval documentation for pharmaceutical veterinary medicinal products (safety, residues and efficacy parts of the dossier), worldwide (except USA)
-Participate in international project teams as European core or sub team member for regulatory affairs and provide regulatory assessment according to current legislation and requirements
-Provide regulatory advice to develop and optimize appropriate registration strategy
-Preparation of registration dossiers and documentation for new products to Operating Units (OPUs)/ licencees/ competent authorities
-Supervision/co-ordination of the answer to list of questions from OPUs/ competent authorities within the project team and assure consistency of the responses to questions received from Operating Units/ competent authorities
-Close cooperation with Pharmaceut. Preclinical-Clinical R&D/ external experts regarding safety, residue and efficacy for the design of safety, residue and efficacy studies and quality/ suitability of study protocols, study reports, expert reports/ Detailed and Critical Summaries and other documentation
-Compilation, preparation and timely submission of appropriate documentation (safety, residue and efficacy part of dossier, variations, renewals) needed to maintain the Marketing Authorisations of previously registered products
-Liaise with European competent authorities
-Graduate degree in veterinary medicine, biology or a similar field
-Broad knowlegde in regulatory affairs for european authorities
-Ideally expertise in the authorisation of veterinary medicine (farm animals)

Weitere Qualifikationen: Regulatory affairs manager