Senior Regulatory Affairs Specialist

About the role

Careers that change lives start here. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

What you'll do

• The Senior Regulatory Affairs Specialist serves as the regulatory lead for assigned product portfolios, supporting market access, product lifecycle management
• The role works closely with commercial, operational, clinical, and global regulatory teams to execute regulatory strategies, maintain licenses
• Manage product registrations, import licenses, renewals, and post-approval change submissions for medical devices in India
• Develop and execute regulatory strategies supporting new product introductions and lifecycle management activities
• Interface with regulatory authorities including Central Drugs Standard Control Organization (CDSCO), State Food and Drug Administration (FDA) authorities

What you need

• 6–10 yrs of experience
• Regulatory affairs
• Documentation
• Medication administration
• Sales
• Telecom
• B.Tech or B.E. or M.Pharm