Global Regulatory Specialist, Development Project within NASH

Are you proactive and able to drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Then come and join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. Apply now! The position We are looking for a Global Regulatory Specialist for a late-stage NASH (Non-alcoholic steatohepatitis) project entering submission phase. It is a strategic position and requires leadership, scientific and regulatory background, and drug development proficiency. The project is pursuing the liver indication NASH where there’s yet no approved medicinal product, with a high unmet medical need, and in a regulatory environment that is still in its infancy. A combination that makes the position truly exiting, and with great room for innovation and drive. You will report to the Senior Director of RA Liver Diseases and take active part in department related activities. The position is based in Greater Copenhagen area, Denmark and we welcome applications from international candidates that are willing to relocate to Denmark. Although there is a preference that you work from our office in Denmark, there is a possibility to work remotely with the right candidate and within a reasonable time zone. Obvious alternative base locations for this role, could be at our USA, Boston or UK, Gatwick offices. In this position, you will be involved in strategic regulatory activities, including:

Contributing to the global regulatory strategy by providing innovative regulatory expertise and tactics throughout the research and development stages and to proactively connect with the entire value chain; also evaluate project risks and recommend regulatory mitigations

Demonstrating subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to a late-stage global development project

Taking lead on regulatory activities and deliverables according to agreed timelines and quality

Overall accountability for specific deliverables such as leading and coordinating preparation of meeting packages to Health Authorities and conducting Health Authority interactions

Taking lead on major submission tracks as submission country lead, where you will be working with stakeholders in affiliates to ensure alignment between local and global regulatory strategies and timely preparation of regulatory documentation

With regulatory leadership you will have a large responsibility, and you will have a major influence and impact on our project development and roll out globally. You will assume the role as challenger who makes an impact, seeks solutions, and drives innovations. By incorporating clinical diagnostics and device aspects into our product lifecycle, we are not only pursuing drug but also product development. You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You will be part of regulatory matrix team driven by a Global Regulatory Lead, where you will collaborate with regulatory colleagues from CMC (Chemistry, Manufacturing and Control), device and digital areas.The position offers ample opportunities for you to continue your individual development in a dynamic, innovative, and collaborative environment. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. QualificationsFor this role, we are looking to connect with candidates who have:

An academic degree such as master’s degree or a Ph.D. within Life and Health Science

Several years of regulatory experience in the pharmaceutical industry with a thorough understanding of the R&D (Research & Development) value chain

Solid track record in preparing and delivering on global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling regulatory documentation for pharmaceutical development (quality, non-clinical and clinical)

Strong pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale

Excellent project management skills

Great communication skills and comfortable using fluent written and spoken English daily

On a personal level, we are seeking someone who possesses proactive and independent drive, who can set direction and motivate cross-functional teams towards shared objectives. A team player who values collaboration and supports colleagues in achieving common goals, you must have an inclusive mindset and respect diversity. Additionally, strong negotiation skills and a solid understanding of business are required. Adaptability and a willingness to embrace change are essential, as you should thrive in challenging and ambiguous situations, approaching them with a flexible and experimental mindset that focuses on uncovering opportunities rather than limitations. Finally, it is an advantage if you have a good sense of humor, and you can keep your spirits high even when under pressure. About the department You will join the expanding department of RA Liver Diseases situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within the serious indication NASH and other chronic liver diseases; indications that severely affect millions of people globally and with no current treatment options. We are currently 12 dedicated and highly engaged employees in the department with diverse background and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. Working at Novo NordiskAt 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Tara Elvang at [email protected]. However, please be aware that she will be out of the office from 13th July until 6th August. As a result, there may be a delay in response during this period. Deadline We will conduct interview on an ongoing basis, so please send your application as soon as possible, but no later than 20 August 2023.To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.