Strategic Regulatory Affairs and Business Development Lead
5 days ago
We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S. As a member of our Regulatory Affairs Diabetes and Obesity team, you will play a pivotal role in creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and approvals of initial Marketing Authorisation applications.
You will have the opportunity to work on cross-functional projects and collaborate with various stakeholders, including deal teams and matrix teams across Regulatory Affairs. Your expertise in regulatory affairs and business development will be crucial in evaluating external assets and companies for in-licensing, partnerships, or acquisitions.
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:- Collaborate with the BD Director and regulatory specialists to evaluate external assets and companies for in-licensing, partnerships, or acquisitions.
- Serve as a strategic business partner within global RA in relation to NN's existing portfolio and lead portfolio-wide initiatives.
- Lead the regulatory assessment that identifies risks and opportunities, achievability of a target product profile, probability of success of the different value creation phases, and a future regulatory strategy that are both ambitious and realistic.
- Ensure alignment with relevant internal functions and/or projects in relation to the future plans and regulatory strategy for the asset.
- 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.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeKey ResponsibilitiesAs a Regulatory Affairs Business Development Director at Novo Nordisk, you will be responsible for:Leading RA BD activities and establishing a Matrix Team covering all relevant regulatory skill areas.Evaluating external assets and companies for in-licensing, partnerships, or acquisitions across Novo Nordisk's therapeutic...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeCompany 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,...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob 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...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertRegulatory Affairs Business Development DirectorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug development...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Regulatory Affairs Business Development Director Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug...
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