Regulatory Publishing Specialist

Publisher I

   

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.

Experience Level

Mid Level