Regulatory Affairs Business Development Director
5 days ago
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Regulatory Affairs Business Development DirectorCategory: 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 development value chain? Can you align promising external assets with Novo Nordisk's strategy, portfolio, and organisation?
If so, then consider joining our team and become a key contributor to Business Development (BD) activities across NN's therapeutic areas, representing Global Regulatory Affairs (RA) within the Global Project BD Team. Apply now for this life-changing opportunity
The position
As a Regulatory BD Director in Global RA, you will 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. Additionally, you will also serve as a strategic business partner within global RA in relation to NN's existing portfolio and lead portfolio-wide initiatives.
Your key responsibilities will include:
- Lead RA 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.
- 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.
- Drive the integration process in RA when agreements are established, ensuring a smooth handover of asset/project to the global regulatory leads.
- In addition to RA BD activities, provide strategic support to the various RA therapeutic areas and engage in cross-project strategic initiatives.
You will be based in Søborg, a suburb of Copenhagen, Denmark. You will report to the Head of RA Business Development.
Qualifications
To be a competitive candidate, we expect you to 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.
- 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.
In this role, strong interpersonal abilities aid in collaborative work, while a keen analytic mindset helps identify value-critical paths and plan future projects. Creativity in problem-solving, alongside adept organisational and communication skills, are essential. This role demands leadership, utilizing communication prowess across organisational tiers, and fostering valuable professional networks that include external collaborations.
About the department
The RA Business Development team is a team of 4 dedicated team members. The team is in the RA Diabetes and Obesity therapeutic area but operates across all therapeutic areas. You will be part of an inspiring work environment with a focus on cross-functional and external collaboration, as well as personal development. We pride ourselves on being passionate about achieving ambitious goals while having fun together.
We are curious and willing to explore new ways of working, developing people through trust and empowerment. Regulatory Affairs Diabetes and Obesity 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. We function as an integral part of the global development organisation and play a pivotal role in cross-functional teams.
Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to improve the lives of patients.
Contact
For more information, please reach out to Katrine Rasmussen at
Deadline
6 April 2025
You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.
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.
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