Regulatory Professional - Rare Disease (Maternity cover)

Category:

Reg Affairs & Safety Pharmacovigilance

Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate? We are looking for a Regulatory Professional to join our Regulatory Affairs team, working on an endocrine project within the rare disease area.

If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity. Then we invite you to join Novo Nordisk as a Regulatory Professional in Regulatory Affairs (RA) in 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 Disorder therapeutic area as a Regulatory Professional in a late-stage clinical project with focus on securing regulatory approval across the globe. In this role, you will support the Global Regulatory Lead in Bangalore within 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.

Your key tasks could include:
• Submission Planning: support regulatory strategy, create and maintain submission plans, create/review documents
• Regulatory File Preparation: Prepare regulatory files, publish, and distribute them as re-quired
• Submission Management: Handle submissions to Health Authorities worldwide, including MAA/NDA/BLA, CTA/IND, PIP/PSP, renewals, post-approval changes, and pharmacovigi-lance documents (DSUR, PSUR, RMP)
• Support Regulatory Interactions: Assist in planning and conducting interactions with Health Authorities, including preparing meeting requests, packages, and taking meeting minutes.
• Core Labeling: Provide input for the development of text for core labeling, including tCCDS/CCDS and European labeling, and support US labeling development. Assist in label development and maintenance throughout the product lifecycle.

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 talent-ed individuals who embrace cooperation, within a culture that empowers and values humility.

You will be located in our Søborg office, working alongside a department of highly engaged em-ployees with diverse backgrounds and experience. Please note that the tasks related to this role will be primarily managed and executed together with our regulatory team based in Bangalore, India.

Qualifications
For this role, we are looking to connect with candidates who have:
• An Master degree in science, pharmacy, biology, or similar
• It is a benefit if you have relevant experience in the pharmaceutical industry, particularly within regulatory affairs within a clinical area
• Demonstrate a strong motivation for processes and systems, which underlines every-thing we do in Regulatory Affairs
• 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 area is responsible for regulatory activities across the entire value chain of drug develop-ment, from drug discovery to research and early development, to clinical development to effec-tive and continuous life cycle management within rare disorders. The area has departments in both our Denmark office and our India office.

We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge shar-ing 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 Ankita Dutta at aitd@novonordisk.com

Deadline
20 of July 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.