Regulatory Business Development Principal Specialist
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Søborg
Are you experienced in developing therapeutic products and skilled at recognizing regulatory risks and opportunities in research or development projects? Do you have a 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? If so, then consider joining our team and become a key contributor to Business Development (BD) activities across regulatory 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 Principal Specialist within Global RA, your role will involve working alongside the BD Director and regulatory specialists in therapy areas to evaluate external assets and/or companies for in-licensing, partnering, or acquisition, with a focus on diabetes and obesity. Your key responsibilities include: Lead RA BD-related activities, establish and drive an RA BD Matrix Team covering all relevant regulatory skill areas, including RA CMC and Device, to ensure a holistic and realistic forward-looking perspective on an asset of interest Build a regulatory assessment that identifies risks and opportunities, achievability of a target product profile, probability of success of the different value creation phases, and the future regulatory strategy Ensure alignment with relevant internal functions and/or projects in relation to the future plans and regulatory strategy for the asset Drive integration when agreements are in place and ensure a seamless handover of asset/project global regulatory leadsMentor and support RA clinical professionals/specialists working on BD activities You will be based in Søborg, a suburb of Copenhagen, Denmark. You will report directly to the Senior Director and Head of RA Diabetes and Obesity Development projects. Some business-related travelling is expected during the year, sometimes at short notice, so flexibility in terms of travelling is required. Qualifications We are seeking a candidate who holds an academic degree, such as a master's or Ph.D., and brings significant experience from regulatory organisations within the pharmaceutical industry. You have been involved in assessment of pharmaceutical assets and performing due diligence. Experience with global regulations and requirements is essential. In addition to the above, we expect you to: Demonstrate ability to set regulatory strategy and lead regulatory projects Perform impact assessments across functions and the value chain, considering regulatory and non-regulatory aspects Display knowledge in medicinal product development (drug or device) with a deep understanding of the drug development and life cycle management process, ideally having led project teams through significant 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 Show keen interest in business development and its principles A 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 You will be joining the department of RA Diabetes and Obesity; however, you will work across all therapeutic areas within Global RA. 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 Development Projects is responsible for creating global regulatory strategies to advance projects across multiple indications, 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. Regulatory Affairs Diabetes and Obesity Development Projects is an expanding area that comprises 24 dedicated and highly engaged leads and regulatory professionals, organised into 3 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 David Truloff at + 45 30790499. Deadline 10 September 2023. We will be screening and interviewing applications on an ongoing basis, so please apply at the earliest. 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 25.8.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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