Global Regulatory Specialist, Development Project within Haemophilia

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 Global Regulatory Affairs (GRA) and become part of an exciting environment where engaged people are committed to obtain 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 haemophilia project entering submission phase. It is a strategic position and requires leadership, scientific and regulatory background, and drug development proficiency.
The project is pursuing indication within haemophilia an area still with a high unmet medical need despite alternative offerings and therefore requires commercial and medical insights combined with solid regulatory experience and ability to apply innovation and regulatory direction setting.
You will report to the Senior Director of RA Rare Bleeding Disorders 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 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.
• 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.
Qualifications
For 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 or 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 Rare Bleeding Disorders 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 are currently 15 dedicated and highly engaged employees in the department with diversity in nationality, 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 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Jane Møll Pedersen [email protected] or +45 30753759.

Deadline
We will conduct interview on an ongoing basis, so please send your application as soon as possible, but no later than 10 September 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.

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.