Regulatory Affairs Specialist II

About the role

Responsible for managing and executing regulatory registration activities across the product lifecycle, including submission, follow-up, and liaison as needed with Health Authorities across International Markets (IM). Provides regulatory expertise, ensures timely responses to authority queries, and maintains accurate regulatory documentation and systems in compliance with GxP requirements.

What you'll do

• Be part of a high-performing, inclusive culture that values fresh thinking and collaboration
• Have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together
• Responsible for managing and executing regulatory registration activities across the product lifecycle, including submission, follow-up
• Manage and support Life Cycle Management activities related to Branded/Specialty and Generic products in IM region in close collaboration with assigned market regulatory…
• Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP

What you need

• 1–4 yrs of experience
• Regulatory affairs
• Documentation
• PowerPoint
• B.Pharm or M.Pharm