Principal regulatory specialist

Principal Regulatory Specialist (Global Regulatory Lead) for innovative development project within Regulatory Affairs, Haemoglobinopathies and Early Development

Are you able to take the lead and drive regulatory strategies for high impact projects, and would you like to work together with experts across multiple functions in a global environment?

Then join Global Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people work with advanced exploratory technologies and diverse therapeutic areas to bring innovative medicines to patients across the globe.

The job

As a Principal Regulatory Specialist in our department, you are expected to demonstrate strong leadership by setting the regulatory strategic direction in 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.

You will be accountable for the regulatory strategy, and you are expected to provide innovative regulatory expertise and tactics with special focus on the later development stages and proactively connect with the entire value chain. You must demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to a global development project.

As part of our department, you will be responsible for planning and driving all regulatory activities and deliverables according to agreed timelines and quality. You will be the overall accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory marketing authorization submissions and approvals globally. For this job you will get the opportunity to be part of a project that is currently in late-stage development within a rare disease and soon will be facing a very exciting period of authority interactions and planning of phase 3.

The job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network – just like we expect you to maintain your external networks to benchmark and bring up discussions with peers.

All in all, with regulatory leadership you will have a large responsibility, and you will have a major influence and impact on our global project development. You will assume the role of the challenger who makes an impact, seeks solutions and drives innovations.

You will report to the Associate Director of RA Haemoglobinopathies and Early Development and take active part in department-related activities, including improvement projects across RA.

Qualifications

Your background covers a master’s degree within life sciences with minimum of 8 years of relevant experience and/or a relevant PhD with minimum of 5 years of relevant working experience.

You have solid experience in preparing and delivering on global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling of regulatory documentation for pharmaceutical development (quality, non-clinical and clinical). You also have a strong pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale. You must have strong negotiation skills and a sound business understanding.

You can think out of the box and suggest unconventional solutions, and you can work with ambiguity and complexity. The job requires that you are well organized, 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 organizational level. Finally, you are comfortable using your fluent written and spoken English daily.

About the department

Haemoglobinopathies and Early Development is part of the department of Rare Blood Disorder within Global Regulatory Affairs, situated in Denmark. In Global Regulatory Affairs, 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 focus on new innovative therapies within therapeutic areas like rare blood disorders and other serious chronic diseases including rare endocrine disorders, NASH and Chronic Cardiovascular and Kidney Disease.

We are currently 21 dedicated and highly engaged employees working in the department, and we have a strong and close collaboration with high level of trust and openness. We work in a fast-paced environment with tight deadlines and deal with the challenging reality of international collaboration across time zones, cultures, and circumstances. 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 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 of its more than 40,000 employees 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 Marie Aavang Geist +45 3448 0290 or Jane Møll Pedersen at +45 3075 3759.

Deadline

4 December 2022

Relevant candidates will be invited for interview also before deadline.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.

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