Øvrige i Søborg

Join Regulatory Affairs (RA) and 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. 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.

The job
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.
You will be accountable for the regulatory strategy, and you are expected to provide innovative regulatory expertise and tactics with special focus on development as well as solid understanding of business acumen 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. 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

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 approvals globally.
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.

All in all, with regulatory leadership you will have responsibilities relating to influencing and impacting global project development. You will assume the role of the challenger who makes an impact, seeks solutions and novel approaches.
You will report to the Senior Director of RA Rare Blood Disorder 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 6-8 years of relevant experience and/or a relevant PhD with 4-5 years of relevant documented working experience.
You have 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. 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.

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

RA Rare Blood 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 Blood Disorders with a pipeline including a variety of different modalities and technologies.
We are a department with 21 dedicated and highly engaged employees of 10 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 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 Katrine Rasmussen +45 3079 0133 or Jane Møll Pedersen at +45 3075 3759.

Deadline

9 November 2022, however relevant candidates may be invited for interview before deadline.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or 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.

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