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Senior Regulatory Affairs Specialist


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The Senior Regulatory Affairs Specialist will be responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for products and communication of general regulatory requirements, supporting Shire´s product licensing activities. In this function you will act as a consultant to manager and key stake holder:

Key objectives:

  • Management of product registration within Europe
  • Technical support for the assigned product(s) in Europe, Middle East & Africa and the Americas/Asia
  • Specifically for the assigned product(s) within the therapeutic area the position has responsibility for the following:
    • Primary contact for technical issues concerning the assigned product
    • Lead or support for discussion, development and coordination of regulatory strategies together with the regional (country) RA function, project groups and line function as appropriate
    • Preparation of technical information and correspondence for contact with health authorities on regulatory projects and particular issues within the product responsibilities in agreement with the Supervisor
    • Communication and coordination of actions with RA LCM Middle East & Africa and the Americas/Asia as well as country-based RA units in agreement with the Supervisor
    • Support of team members of the respective projects within the therapeutic groups
    • Study of regulatory directives and guidelines and active exchange with Regulatory Affairs Product Owners
    • Communication with other therapeutic groups within RA and harmonization of strategies relating to issues of common interest in agreement with the Supervisor
    • Evaluation of change controls for their impact on European licenses
    • Follow-up of compliance issues and elevation to line function
    • Provision of manuscripts of labeling material and review of final printed labeling in agreement with the Supervisor

Key requirements:

  • At a minimum: Bachelor?s degree or country equivalent in pharmacy or related scientific discipline - higher degree / PhD will be a strong advantage
  • Broad scientific knowledge and interest
  • A minimum of 5 years experience  within a pharmaceutical company, CRO, or similar organization, preferable in Regulatory Affairs environment
  • Strong knowledge of regulations (national/international)
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multitask and prioritize
  • Written and Verbal communication skills in English and German

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is €   3,065.25 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.

Austria

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