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Regulatory Affairs Manager (f/m) Vienna Austria,  


Posted on : 01 July 2017

Project Description

 As part of our Regulatory Affairs team you will play a key role in Life Cycle Management of existing approvals and submission of new regulatory projects.Ready for an ambitious job?You are planning and coordinating the compilation of global regulatory submission documents according to country specific requirementsPrepare all labelling documents and track timely submission at the authoritiesYou manage change control processes and oversee post-approval activitiesYou are responsible for regulatory data management (DocuBridge)and electronical xEVMPD (IDMP) reportingAble to align?You enjoy working in a high-performing international environment You provide regulatory know-how to Project Teams involved in the development of new products You are a team player and like to work cross-functionally and with external partnersLooking for an agile environment?You prefer a high degree of independence and responsibility for assigned projectsYou enjoy to work in a growing international company introducing solutions for rare diseases to new marketsYou have a pro-active attitude, the ability to develop new concepts and a creative approach to problem-solvingProfessional skillsUniversity degree in Natural Science/, Pharmacy, Medicine or comparable education 3-5-year Regulatory Affairs experience in the pharmaceutical industry In-depth knowledge of international regulatory requirements Ability to strategically plan and manage multiple projectsAttention to detail and ability to prioritizeStrong communication skills to liaise with internal and external partners with different cultural background in English and GermanThe gross monthly salary provided for this function is a minimum of

Locations

1160 Vienna, Austria

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