Company:
Novo Nordisk Global Business Services (GBS)

Shape global regulatory strategies that bring cutting-edge therapies from pipeline to patients – navigating complex health authority landscapes across the world while driving the future of how we work with regulatory science.

Your current role
In this role, you will take ownership of regulatory strategies and submissions across global markets, acting as a key driver in ensuring our therapies reach patients efficiently and compliantly. You will operate at the intersection of science, strategy, and stakeholder management – balancing deep regulatory expertise with cross-functional collaboration.

Your Key Responsibilities Span Across Several Areas
Regulatory submissions to health authorities worldwide
Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies
Prepare, submit, and maintain regulatory files including MAA/NDA/BLA, CTA/IND, Site Master Files, renewals, post-approval changes, and commitments




Respond to questions from health authorities and maintain marketing authorisations globally
Manage interactions with affiliates to ensure aligned and timely execution

Regulatory interactions with health authorities
Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals, and formal meeting minutes
Provide strategic input to affiliates for preparation of health authority interactions

RA matrix team membership
Represent the Regulatory Affairs function in the RA matrix team, ensuring alignment of planning and strategy across areas
Drive effective information flow to the matrix team to support decision-making

Monitor and renewals handling
Drive monitoring of upcoming submissions in Vault RIM, assess required national documentation, and conduct high-level planning
Own the overall planning and initiation of global renewals

Role as Global RA CMC Lead
Be accountable fo

📌 Sr Regulatory Professional Bengaluru East (India)
🏢 Novo Nordisk
📍 India