Manager, Labelling

About the role

In this role, the manager needs to provide regulatory strategy and direction to the business regarding healthcare industry regulatory by working closely with US FDA and Health Canada. Leads and manages a team of Regulatory Affairs based in India for the following:

What you'll do

• AI Strategy & Governance
• Develop and execute the AI roadmap for Regulatory Affairs, ensuring alignment with global regulatory requirements and business objectives
• Partner with Regulatory, Global Labeling, and CMC teams to identify AI opportunities that enhance efficiency, compliance, and decision-making
• Guide users on the effective and responsible use of AI tools, including Copilot, and deliver training programs to support adoption
• Monitor regulatory trends, competitor activities, and evolving guidelines to provide strategic insights

What you need

• 15–27 yrs of experience
• Regulatory affairs
• PowerPoint
• Pharmacovigilance
• SOP writing
• Documentation
• Data privacy
• Any graduate

Good to have

• Employee engagement