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Regulatory Affairs Expert in Business Development

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Company Overview:

Novo Nordisk A/S is a leading healthcare company that focuses on developing innovative treatments for people with diabetes and other serious chronic conditions. Our vision is to make a significant difference in patients' lives by delivering high-quality products and services.

We are committed to fostering a culture of innovation, collaboration, and continuous improvement. Our employees are passionate about making a positive impact on patients' lives, and we strive to create a work environment that supports their growth and development.

In this role, you will have the opportunity to work with a talented team of professionals who share your passion for improving patients' lives. You will be responsible for 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 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.

You will be based in Søborg, a suburb of Copenhagen, Denmark, and will report to the Head of RA Business Development. We offer a dynamic and inspiring work environment with a focus on cross-functional and external collaboration, as well as personal 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.