Regulatory Officer - Bad Homburg, Deutschland - Viatris

    Viatris
    Viatris Bad Homburg, Deutschland

    vor 2 Wochen

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    Ganztags
    Beschreibung
    Mylan Germany GmbH

    At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

    Viatris empowers people worldwide to live healthier at every stage of life.

    We do so via:

    Access – Providing high quality trusted medicines regardless of geography or circumstance;
    Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
    Partnership – Leveraging our collective expertise to connect people to products and services.

    Every day, we rise to the challenge to make a difference. As a Regulatory Affairs Officer (m/f/d) in the local Regulatory Affairs Department Germany you will be responsible for the following tasks:

    Key responsibilities for this role include:

  • Screening, processing, and tracking of CPP requests
  • Communication with CTS team regarding local particularities for CPPs
  • Preparation of CPPs with information from requestor.
  • Diligent verification of information in CPP with authorized information.
  • Application of CPPs at local authority in Germany
  • Initiation and coordination of required legalization procedure
  • Shipment and tracking of CPP applications to local authorities and to requesting countries.
  • Cost tracking for requests, issuing at local authority and legalization.
  • Filing, review and distribution of print and digital-PI-texts for the marketed product portfolio of VIATRIS in Germany (patientinfo-service, SmPC TrackingSystems).
  • Submissions via German HA portal (PharmNet.Bund), e.g. reports on drug shortages, sunset clauses, product information texts (PIT) and national variations.
  • Maintenance of local and global database entries of VIATRIS procedures approved in Germany.
  • Revision and maintenance of local work instructions and standard operating procedures (SOP) in the global document management system.
  • Collaboration in national and international projects
  • Support with regulatory life cycle management of products approved and registered in Germany by VIATRIS companies such as Viatris Pharma and affiliated companies (if applicable).

    • The minimum qualifications for this role are:

  • Degree in pharmacy, biology, or chemistry
  • Basic knowledge of regulatory affairs (labelling / CMC)
  • Basic knowledge of regulatory guidelines (European and national)
  • Experience with database maintenance and document management systems
  • Strong skills of Microsoft 365 applications (Outlook, Teams, Excel, Word)
  • Strong verbal and written communication skills (German/English)
  • Careful and accurate work
  • Work in a cross-departmental team with local and global colleagues

    • At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

    Viatris is an Equal Opportunity Employer.