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Regulatory Compliance Manager

3 maanden geleden

Alphen aan den Rijn, Zuid-Holland, Nederland Novo Nordisk Voltijd
Regulatory Compliance Manager

Category:

Reg Affairs & Safety Pharmacovigilance
Location:Alphen aan den Rijn, Zuid-Holland, NL- 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 uptodate 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 healthcarerelated 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.
Working at Novo Nordisk

  • We are a proud lifescience company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things from the building blocks of life that form the basis of groundbreaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here to ensure that people can lead a life independent of chronic disease.
    ContactDeadline*
  • We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
  • At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.