(Senior) Regulatory Professional for Rare Disease Area (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Are you able to cut through complexity and drive regulatory strategies for high impact projects particularly in Rare Disease? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of an exciting area where engaged people are committed to bring innovative treatment to patients across the globe?

we invite you to join Novo Nordisk as a Senior Regulatory Professional in Regulatory Affairs (RA) for a 12-month maternity cover. Our people possess a distinctive blend of scientific expertise, a patient-centric approach, and the capability to navigate various agendas and stakeholders. Take the next step by submitting your application today!

The position
We have a vacant position within the “Rare Blood Disorder” therapeutic area as a Senior Regulatory Professional in a project with focus on late-stage clinical development approaching regulatory submission. In this role, you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.

Key responsibilities include:

• Contributing to global regulatory strategies and tactics by providing your knowledge via analysing regulatory opportunities and risks
• Ensuring that the project strategy is implemented in the planned submission country roll-out and lead the launch planning process from a regulatory perspective
• Developing regulatory documentation for submission to Health Authorities, e.g. meeting packages, paediatric plans and MAAs/NDAs/BLAs
• Collaborating with project management, medical and non-medical specialists, statisticians, and medical writers.

Your contribution in this position is crucial for delivering cutting-edge solutions that prioritize patients, fostering innovation, and achieving excellence. This necessitates a strong sense of teamwork, communication skills, collaboration, and expertise among your colleagues, as well as a deep commitment to sharing knowledge. Prepare to be immersed in an environment of talented individuals who embrace cooperation, within a culture that empowers and values humility.

Qualifications
For this role, we are looking to connect with candidates who have:

• An academic degree in life science or similar, may be supplemented with a PhD degree
• Solid and hands-on regulatory or/and drug development experience
• Good pharmaceutical industry knowledge
• Proficiency in interacting with regulatory authorities on an international scale would be an advantage
• Strong IT/digital skills
• Ability to communicate in fluent English (both written and spoken)

As a person, you thrive in a fast-paced work environment characterized by ambiguity. You bring a can-do spirit and a healthy sense of humour to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations.

It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level.

About the department
The department is responsible for Rare Blood disorders with projects in early and late-stage development going into the submission phase. The department consists of 13 highly engaged employees 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.

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 Karen Schumann at [email protected]

Deadline
26 of January 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.