Company: Novo Nordisk Global Business Services (GBS)

Shape regulatory strategies that bring life-changing medicines from development through approval – and into the hands of patients across the globe.

Your current role

As a CMC Regulatory Specialist, you will take ownership of complex regulatory processes that directly enable Novo Nordisk's medicines to reach patients worldwide. Operating at the intersection of science, strategy and global compliance, you will navigate diverse regulatory landscapes and drive submissions across major markets. Your work will span the full product lifecycle – from early development through post-approval – requiring both deep technical expertise and strategic agility.

Your responsibilities will span the following key areas:

*Regulatory submissions to health authorities worldwide*
- Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies across global markets
- Prepare, maintain and submit regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master files, renewals,



post-approval changes and commitments
- Respond to questions from health authorities and manage ongoing interactions with affiliates to ensure alignment and compliance

*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 in preparation for health authority interactions
- Represent Novo Nordisk externally, actively communicating within your field of expertise

*RA matrix team membership and cross-functional collaboration*
- Represent the Regulatory Affairs function in RA matrix teams, ensuring alignment of planning and strategy across areas
- Ensure effective information flow to the matrix team and broader stakeholders
- Serve as RA representative in International Study Groups, stakeholder working group

📌 CMC Regulatory Specialist (Bengaluru)
🏢 novonord
📍 Bengaluru