Junior Regulatory Affairs Specialist (f/m) Part-time (19 hours per week)

      ISG Personalmanagement GmbH

      Wien - vor 1 Monat

      Our customer is a renowned company which operates in the international pharmaceutical industry. The own research & development, innovative products and a company strategy which is long-term orientated are key factors for their success.

      For the further development we are looking for a dynamic and ambitious personality, who is based in the office in Vienna, as:

      Junior Regulatory Affairs Specialist (f/m)

      Part-time (19 hours per week)

      Your Tasks:

      • Translation, preparation or review of SPC/labelling/leaflet texts from Company`s respective new and in-line products registered in the countries, or coordination of these activities - under supervision
      • Artwork revision for AT and coordination within sub-region
      • Support in preparing Application Forms and other local documentation including payment of registration fees
      • Tracking the product status and product maintenance in appropriate database
      • Cultivating best possible relations with local regulatory bodies
      • Under supervision of DRA Manager handling all issues related to changes in the Company's products status in line with regional strategy and performing regulatory related surveys in the region
      • Dealing with pharmacovigilance related issues within the appropriate region (reporting of PV cases, databases update, training of the colleagues, keeping the pharmacovigilance archive, PSUR submission)
      • Support DRA Manager in marketing material revisions
      • Establishing and maintaining support and good contacts within corporate, regional and local regulatory teams, business, marketing and logistic functions, taking into consideration
      • Company's interests and normative requirements
      • Effectively communicate with regulatory authorities

      Your Qualifications:

      • Scientific background (ideally Veterinary Medicine, Pharmaceutical, Biological or Chemical university education)
      • German (at least B2), English (fluent in writing and verbal)
      • Computer literacy (MS Office)
      • Past experience in Regulatory Affairs (not necessary but welcome)
      • Willing to learn new things, implementation of legal conditions into in-house procedures
      • Ability to work remotely with the team of the cluster countries and thus cultivating the relationship and team spirit within multi-cultural environment
      • Motivation in details and analyses of scientific/regulatory texts
      • Being able to work towards priorities and under time-pressure
      • Ability to read drug law legislation and authority requirements in Austria and CEE region
      • Willing to develop the career within Regulatory Affairs and Pharmacovigilance

      The Offer:

      • Diversified tasks in an international environment
      • An employer with an excellence reputation
      • Our customer offers a monthly gross salary from EUR 1.800.- (based on 19 hours per week) with willingness of overpayment depended on your qualifications and relevant experience as performance based premiums and attractive fringe benefits
      • An appreciative work environment

      If you are interested in this challenging position we are looking forward to receiving your comprehensive application (motivation letter plus resume) for ref.no. 67.827 via eMail or through our ISG career portal.

      ISG Personalmanagement GmbH
      A-1020 Wien, Rustenschacherallee 38
      Mag. Birgit Prochazka, T: +43 1 512 35 05-16
      eMail: bewerbung.prochazka@isg.com