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 new 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)
🏢 Novo Nordisk
📍 Bengaluru East