Regulatory Affairs Specialist for innovative development within Rare Disease

Do you want to become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines by regulatory authorities across the globe? If yes, you could be our new Regulatory Specialist.

Regulatory Affairs is a fast-changing field where no two days are alike, and the engaged employees in our unit need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. That makes RA a truly interesting and challenging place to work.

Apply now for a life-changing career!

The position 
As a Regulatory Specialist in our department, you are expected to demonstrate leadership by setting the regulatory strategic direction in innovative development projects and in highly scientific settings. You will work as an integrated part of global cross-functional project-teams with stakeholders ranging from research to development, market access, commercial and to our Novo Nordisk affiliates worldwide.

Your main responsibilities will include:

• Execute and drive the regulatory strategy to obtain approvals 
• Provide innovative regulatory expertise and tactics with special focus on development as well as solid business acumen and proactively connect with the entire value chain
• Demonstrate subject matter expertise within regulatory science and global development projects 
• Be responsible for planning and driving regulatory activities and deliverables according to agreed timelines and quality
• Be the overall accountable for specific deliverables such as submission and approval of clinical trial applications
• Drive and coordinate preparation of meeting packages to Health Authorities, conducting Health Authority interactions

The job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. You will assume the role of the challenger who makes an impact, seeks solutions and novel approaches. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network.

You will report to the Senior Director of RA Rare Bleeding Disorders and take active part in department related activities, including improvement projects across RA.

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based.

Qualifications
To be a competitive candidate, you should have:

• A master’s degree within life sciences with 6-8 years of relevant experience and/or a relevant PhD with 4-5 years of relevant documented working experience
• Experience 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
• Strong pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale
• Experience within rare disease is an advantage
• Strong negotiation skills and a sound business understanding
• Professional proficiency in English 

The job requires that you are well organised, work structured and have solid problem-solving capabilities. You have a good sense of humor, and you can keep your spirits high even when under pressure. You are an excellent communicator who can cooperate and influence at any organisational level. 

You possess high level of innovation to deal with completely new situations and often in an international context. Solves complex problems; takes a new perspective using existing solutions or via suggestion of completely new and innovative approaches. Bold mindset and approach towards regulatory tactics and scenarios linking to business opportunities.

About the department
RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies. 

We are a department with 15 dedicated and highly engaged employees of 7 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing. 

Contact
For further information, please contact Jane Møll Pedersen at +45 3075 3759.

Deadline
30 March 2025

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.