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Alphen aan den Rijn

    Regulatory Compliance Manager - Alphen aan den Rijn, Nederland - Novo Nordisk A/S

    Novo Nordisk A/S
    Novo Nordisk A/S Alphen aan den Rijn, Nederland

    1 week geleden

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    Beschrijving

    Are you passionate about ensuring that promotional materials meet regulatory standards? Do you thrive in a dynamic environment where compliance is key? If so, we've got the perfect opportunity for you at Novo Nordisk

    As a Regulatory Compliance Manager you will be mainly responsible for review of (non)promotional materials and documents related to promotional activities to ensure compliance with CGR (pharmaceutical advertising code) requirements. In this role you will also actively participates in Regulatory Affairs (RA) processes.

    This position offers part-time hours, 32 hours per week, spread over 4 days, with a hybrid work arrangement.

    The Position

    You will:

  • Ensure promotional materials adhere to local legislation (CGR) and Novo Nordisk's ethical standards. Provide training and support to ensure employees understand regulatory requirements.
  • Collaborate with local RA team to optimize registration processes and ensure compliance. Write clear product information leaflets and labels, review packaging proofs, and manage relevant documents.
  • Maintain up-to-date knowledge of local and EU regulatory requirements. Act as a specialist within the affiliate, providing expertise to internal and external partners.
  • Stay informed about relevant legislation, regulations, and guidelines to ensure compliance and mitigate risks.
  • Cultivate relationships with internal and external stakeholders to optimize daily operations and ensure compliance with local legislation, SOPs, and business ethics requirements.

    • Qualifications

    To be successful in this role, we expect you to have the following qualifications:

  • Bachelor's degree in Life Sciences or related field (HBO), or equivalent experience in the pharmaceutical industry.
  • Proficiency in Dutch and English languages.
  • Familiarity with CGR and EFPIA regulations, as well as regulatory licensing processes for medicinal products.
  • Demonstrated track record in the pharmaceutical industry or a healthcare-related role.

    • About the Department
    Be part of an exceptional team comprising 8 dynamic professionals, each specializing in one of four key functions: Drug Safety, Regulatory Affairs, Customer Service, and our exciting new addition, Regulatory Compliance.

    This is a newly created role and you'll report directly to the Manager of Regulatory Affairs/Drug Safety & Medical Services, contributing to our collaborative and innovative work environment. We value diversity and teamwork and are always supportive of each other.

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