Publisher I

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 energetic, 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

Experience Level

Mid Level

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Publisher (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru