Regulatory Business Development Director

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Do you have solid experience in developing therapeutic products? Can you identify the regulatory risks and opportunities in a research or development project? Do you have good understanding of the therapeutic value chain? Can you ensure alignment of promising external assets to Novo Nordisk with the relevant strategy, portfolio, and organisation? Do you want to drive Business Development (BD) activities across the regulatory therapeutic areas and representing Global Regulatory Affairs (RA) in a “Global Project BD Team”? If so, then this opportunity could be right for you.

 

The position

 

As BD Director within Global RA you will, together with the receiving therapy area, be responsible for the assessment of external assets and/or companies for in-licensing, partnering or acquisition. The asset can range from research modalities, therapeutically broad research assets, to a more specific therapeutic development candidate, or even a drug delivery device. It might also range from a diagnostic tool to a digital solution with potential to support the Development organisation.

 

Your tasks will be to:

  • Cover BD related activities across all therapeutic areas, establish and drive an RA BD Matrix Team covering all relevant regulatory skills areas, including RA CMC and Device
  • Work closely with the receiving therapeutic area within RA to ensure a holistic and realistic forward looking perspective on an asset of interest   
  • Build a regulatory assessment that identifies risks and opportunities and define the regulatory Probability of Success of the different value creation phases
  • Contribute to an achievable Target Product Profile, and a realistic and actionable development plan to support valuation of the asset
  • Ensure alignment with relevant internal functions and/or projects in relation to the future plans for the asset
  • Ensure appropriate briefing of and alignment with Regulatory Leadership, and relevant senior stakeholders
  • Build a Playbook for Regulatory BD activities and collect and communicate learnings from previous BD activities
  • Ensure learnings are brought back to the functional areas and projects
  • If closing a deal, drive integration (data transfer, system and organisation integration), onboarding, training activities, etc.
  • Drive seamless handover of asset/project to the receiving therapeutic area after deal closing
  • Mentor and support RA clinical professionals/specialists working on BD activities

 

You will be based in Søborg, DK and report to Senior Director , RA NASH. Some business related travelling is expected during the year, sometimes at short notice, so flexibility in terms of travelling is required.

 

Qualifications

You have an academic degree such as a master’s degree or a Ph.D. combined with several years of regulatory experience in the pharmaceutical industry with a thorough understanding of the R&D value chain. It is important that you have global experience. You have strong inter- and intrapersonal skills, and to succeed in this role you must have strong indirect leadership capabilities.  

 

In addition, we expect you to,

  • Have successful project management experience from leading projects
  • Have strong regulatory experience in preparing and delivering on global regulatory strategies throughout the research and development life cycle. You must be able to perform impact assessments not only focusing on regulatory aspects but also to connect dots across the value chain and various functions in collaboration with non-clinical, Medical & Science, commercial, patient access, legal, product supply, and other relevant SMEs
  • Demonstrate proactive and strong leadership and know how to set direction, lead, and motivate a team to work for joint objectives
  • Think out of the box, suggest unconventional solutions, and work with ambiguity and complexity. The job requires that you are well organized and have solid problem-solving capabilities
  • Demonstrate strong analytic mindset with the ability to identify the critical path and the parameters critical for value creation, and the skillset to design and drive an assessment process and future project plans
  • Medicinal product (drug or device) development understanding and knowledge on the drug development and life cycle management process, preferably from leading project teams through substantial parts of the product development life cycle
  • Strong communicative capabilities

 

In addition, it is an advantage if you have:

  • Knowledge of the commercialisation of pharmaceuticals
  • Documented ability to create strong professional networks including external collaborations 

 

About the Department

You will be joining the department of RA NASH but cover and support all therapeutic areas within Global RA. Within RA we work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally.

You will be part of an inspiring work environment with focus on cross-functional and external collaboration, and personal development. We pride ourselves in being passionate about reaching ambitious goals while having fun together, we are curious and dare to explore new ways of working and we develop people through trust and empowerment. 

 

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 Tara Elvang at +4530752456.

 

Deadline

19 February 2023

Please notice that applications will be processed as they are received.

 

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.