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Regulatory Affairs Business Development Director Position

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Job Description:

We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S.

The successful candidate will have a strong background in regulatory affairs and business development, with experience in evaluating external assets and companies for in-licensing, partnerships, or acquisitions. They will also serve as a strategic business partner within global regulatory affairs in relation to Novo Nordisk's existing portfolio and lead portfolio-wide initiatives.

The key responsibilities of this role include leading RA BD activities, establishing a matrix team covering all relevant regulatory skill areas, and ensuring alignment with relevant internal functions and/or projects in relation to the future plans and regulatory strategy for an asset.

The ideal candidate will have a master's degree and/or Ph.D., and a minimum of 10 years of experience from regulatory organisations within the pharmaceutical industry or from working at a Health Authority. They will also have experience with global regulations and requirements, regulatory strategies and projects, and performing impact assessments across functions and the value chain.

This is an exciting opportunity for someone who wants to work on cross-functional projects and collaborate with various stakeholders. The successful candidate will be based in Søborg, a suburb of Copenhagen, Denmark, and will report to the Head of RA Business Development.

Key Responsibilities:
  • Lead RA BD activities and establish a matrix team covering all relevant regulatory skill areas.
  • Ensure alignment with relevant internal functions and/or projects in relation to the future plans and regulatory strategy for an asset.
  • Drive the integration process in RA when agreements are established, ensuring a smooth handover of asset/project to the global regulatory leads.
  • Provide strategic support to the various RA therapeutic areas and engage in cross-project strategic initiatives.
Requirements:
  • A master's degree and/or Ph.D.
  • Minimum 10 years of experience from regulatory organisations within the pharmaceutical industry or from working at a Health Authority.
  • Experience with global regulations and requirements, regulatory strategies and projects.
  • Experience performing impact assessments across functions and the value chain.
  • Comprehensive expertise in medicinal product development (drug or device) with a thorough understanding of the drug development and lifecycle management process.