Company: Novo Nordisk Global Business Services (GBS)

Shape global regulatory strategies that bring innovative therapies to patients worldwide. If you thrive on complexity, enjoy building bridges across borders and want your work to directly influence how health authorities view our pipeline – this role is for you.

Your current role

As a Regulatory Skilled, you will drive regulatory submissions and strategy development across global health authorities, while mentoring colleagues and contributing to the continuous evolution of our regulatory practice. You will work in a dynamic workplace where strategic thinking, proactive problem-solving and cross-cultural collaboration come together every day.

Your key responsibilities will include:
Driving regulatory submissions to health authorities worldwide: lead submission planning, apply regulatory intelligence and develop strategy; drive preparation, maintenance and submission of regulatory files (MAA/NDA/BLA, CTA/IND, Site Master File, renewals, post-approval changes and commitments) and lead interactions with affiliates




Supporting health authority interactions: contribute to the planning and conduct of regulatory authority interactions, including meeting requests, meeting packages, rehearsals and minutes from formal meetings, and provide input to affiliates preparing for their own health authority engagements
Representing RA in the matrix team: ensure alignment of planning and strategy across areas and secure a solid information flow between the RA function and the wider matrix team
Monitoring submissions and handling renewals: drive monitoring of upcoming submissions in Vault RIM, assess national documentation requirements, conduct high-level planning and take responsibility for the overall planning and initiation of global renewals
Evaluating guidelines and driving innovation: stay ahead of evolving regulatory landscapes and contribute to innovation projects that strengthen how we work
Mentoring and tr

📌 Regulatory Professional Ii Bengaluru (India)
🏢 Novo Nordisk
📍 India