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Regulatory Affairs Technician (m/f/d)

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Description

As a Regulatory Assistant within the Life Cycle Management function of Regulatory Affairs, you will be responsible for the organisation, tracking and dispatch of key administrative documents for regulatory submissions. These include, but are not limited to:

  • Requests for Free Sale Certificates

  • Certificates of Pharmaceutical Products

  • Power of Attorney and Price Certificates

  • Initiation and tracking of notorisation and/or legalization of such documents in accordance with local country requirements

  • Co-ordination of requests for product samples which are required for local country product registrations working closing with the quality and supply chain organisations to ensure the dispatch of such samples and associated documentation

  • Management and supervision of contracts with external partners, including setting up of Purchase Orders, organisation of extension to contracts, budget spend tracking and management of entries in the appropriate systems to ensure compliance and oversight

  • Co-ordination and tracking of document translation requests through an external vendor.



Qualifications

  • Qualification as "Pharmazeutisch-kaufmännische/r Angestellte/r (PKA), Pharmazeutisch-Technischen Assistent/in (PTA) or Medizinische/r Dokumentationsassistent/in"

    ·Excellent administration / organisational skills with the ability to organise and prioritise to successfully meet conflicting deadlines and multiple tasks

    ·Relevant working experience of 2 to 3 years

    ·A good team spirit with proven team working skills

    ·Strong communication skills

    ·Proficient in use of MS office and other databases

    ·Competent in working with multiple stakeholders

    ·English and German fluently written and spoken


Job locations:
Darmstadt, Hesse
Job Type: Full-time Req No: RND00004037
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