Company: Novo Nordisk Global Business Services (GBS)

Shape how life-changing therapies reach patients around the world. As a Sr Publisher, you'll drive the regulatory publishing and submission delivery that turns scientific breakthroughs into approved medicines – and you'll do it with a level of independence, influence and impact that few publishing roles can match.

Your new role
As a Sr Publisher I/II, you will independently drive regulatory publishing and submission delivery for marketing applications and lifecycle management activities, both regional and global. You will ensure eCTD compliance in accordance with Health Authority requirements while acting as a subject matter expert and lead publisher on assigned projects.

Your key responsibilities will include:
- Leading the planning, compilation, publishing, technical validation, and timely dispatch of regulatory submissions – including MAAs, NDAs and post-approval change submissions – in line with country-specific requirements
- Driving publishing and compilation of clinical, non-clinical and safety documents,



ensuring adherence to approved templates, style guides, timelines and publishing standards
- Acting as the lead publisher for assigned projects/products, serving as the primary stakeholder contact and driving end-to-end publishing activities to ensure submission readiness
- Performing and overseeing electronic quality control (eQC) of published documents intended for regulatory submissions
- Driving process improvement and optimisation initiatives to enhance publishing efficiency, quality and compliance – including the development of SOPs, templates and best practices
- Strengthening capability development through onboarding, training, mentoring and structured knowledge sharing across the publishing team
- Driving inspection readiness, ensuring adherence to GxP standards and proactively identifying compliance risks

Your recent department
In Research & Development, you'll be part of a unit that explores bo

📌 Sr Publisher I/ II (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru