Regulatory Affairs Business Development Director Position

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Department

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The Regulatory Affairs Diabetes and Obesity therapeutic area is responsible for creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and approvals of initial Marketing Authorisation applications.

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As a key member of this team, you will collaborate with cross-functional groups, including deal teams, and provide strategic support to various RA therapeutic areas and engage in cross-project strategic initiatives.

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You will have the opportunity to work on exciting projects and contribute to Business Development (BD) activities across Novo Nordisk's therapeutic areas, representing Global Regulatory Affairs within the Global Project BD Team.

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Key Responsibilities

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  • Lead Regulatory BD activities and establish a Matrix Team covering all relevant regulatory skill areas, including RA CMC and Device, to ensure a comprehensive and holistic perspective on an asset of interest.">
  • Collaborate with the BD Director and regulatory specialists to evaluate external assets and companies for in-licensing, partnerships, or acquisitions across NN's therapeutic areas.">
  • Develop and implement regulatory strategies that align with Novo Nordisk's strategy, portfolio, and organisation.">
  • Serve as a strategic business partner within global RA in relation to NN's existing portfolio and lead portfolio-wide initiatives.">

Qualifications

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To be a competitive candidate, we expect you to have:

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  • 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.">
  • Experience with global regulations and requirements, regulatory strategies, and projects.">
  • Experience performing impact assessments across functions and the value chain, considering regulatory and non-regulatory aspects.">
  • Comprehensive expertise in medicinal product development (drug or device) with a thorough understanding of the drug development and lifecycle management process, ideally having led project teams through key phases of the product lifecycle.">
  • Be capable of collaborating within cross-functional groups, including deal teams, and providing direction in matrix teams across Regulatory Affairs.">
  • Knowledge of commercialisation of pharmaceuticals is an advantage.">

About You

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We are looking for a talented and experienced professional who can drive the integration process in RA when agreements are established, ensuring a smooth handover of asset/project to the global regulatory leads.

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As a strong communicator, you will be able to work effectively with internal functions and external partners to achieve our goals.

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Benefits

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We offer a dynamic and inclusive work environment with opportunities for personal and professional growth.

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At Novo Nordisk, we strive to make a positive difference in the lives of patients and communities around the world.

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Contact

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If you are interested in this opportunity, please submit your application.

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