Novo Nordisk

Regulatory Professional I

Novo Nordisk  •  Bengaluru, IN (Onsite)  •  4 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Company: Novo Nordisk Global Business Services (GBS)


Shape the future of regulatory publishing in an integrated model where clinical and regulatory expertise meet AI, automation and global impact – helping bring life-changing therapies to patients faster.

Your new role
As a Publisher, you will operate within an integrated Clinical and Regulatory Publishing model, enabling seamless delivery of high-quality submissions and documents across both clinical and regulatory domains. You will play a critical role in ensuring compliant, efficient, and technology-enabled publishing across the full submission lifecycle for clinical documentation and regulatory dossiers.

Your day-to-day responsibilities will include:

  • Performing regulatory publishing and submission delivery for marketing applications and lifecycle management activities (regional and/or global), ensuring eCTD compliance in accordance with Health Authority requirements
  • Carrying out document publishing activities in clinical, non-clinical and safety domains, adhering to approved templates, standards and timelines
  • Collaborating with cross-functional stakeholders to ensure integrated Clinical and Regulatory publishing delivery
  • Making recommendations for new procedures and continuously focusing on optimising current processes and ways of working
  • Ensuring compliance with evolving global regulatory guidelines and submission standards, while enabling a flexible, multi-skilled publishing model that supports scalable delivery
  • Contributing to process improvements by leveraging AI, automation and digital tools to enhance document preparation and submission efficiency
  • Supporting and participating in knowledge sharing and mentoring activities across the team

Your new department

RQC operations Publishing is responsible for delivering high-quality electronic submissions across the product lifecycle.

We are transforming into an integrated organisation that combines Clinical and Regulatory Publishing capabilities, enabling greater flexibility, scalability, and impact in supporting global submissions.

The team in Bangalore plays a critical role in enabling this transformation and supporting global regulatory strategies.

Your skills & qualifications
We're looking for a Publisher who thrives in a dynamic, technology-driven environment and is passionate about delivering quality submissions that ultimately reach patients. To be successful in this role, we expect that you have:

  • A Bachelor's or Master's degree in pharmacy, life sciences, or a related field – an advanced degree is preferred
  • 4+ years of relevant working experience within Regulatory Operations or Regulatory Affairs and document publishing
  • Experience using Vault RIM in a regulatory and document management context, along with hands-on experience in dossier compilation and publishing using eCTD, NeeS, and standard submission formats
  • Exposure to clinical document publishing (e.g. protocols, CSRs) is preferred, as is experience or interest in digital tools, automation, or AI-enabled solutions
  • Strong project management, coordination, communication and stakeholder-management skills, with the ability to work independently while collaborating effectively with global teams

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline
23 June 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk

About Novo Nordisk

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic disease and create long-term health.

Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and work to treat, prevent, and even cure diseases that affect millions of lives. Founded in Denmark in 1923, today we employ more than 77,000 people in 80 offices around the world – all united by our bold purpose to drive change to defeat serious chronic diseases. Want to learn more? Visit www.novonordisk.com.

This page isn’t intended for discussions about products. As such, postings or comments that contain product discussions may be removed. This page is for discussions about Novo Nordisk and its subsidiaries and the initiatives and projects we are involved in. While we welcome everyone to make comments, we reserve the right to remove those that are off-topic, abusive or intended to spam.

Any questions specific to products should be made to your healthcare professional. If you wish to file an adverse drug reaction please contact Novo Nordisk’s office in the country you live in:

https://www.novonordisk.com/contact-us/find-local-information.html

For other customer complaints, please contact us here:

https://www.novonordisk.com/contact-us.html

Please keep in mind that Novo Nordisk A/S and its subsidiaries work within a highly regulated industry. Therefore, comments that pertain to legal matters or regulatory issues may be removed.

Comments contained on this site come from members of the public, and do not necessarily reflect the views of Novo Nordisk A/S. Novo Nordisk A/S does not endorse or approve any content added by other LinkedIn users.

Learn more about our privacy disclaimer and community guidelines here: https://www.novonordisk.com/data-privacy-and-user-rights/social-media-privacy-disclaimer.html

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Bagsværd, DK
Year Founded
1923
Social Media