Sr. Regulatory Affairs Specialist

About the role

This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as CDSCO import licences and associated registrations activites in India, and product registration in Australia, Saudi Arabia, the United Arab Emirates, Singapore, Malaysia, the Philippines, and Thailand.

What you'll do

• Coordinate, author, and prepare regulatory submissions, including CDSCO import licence applications (Form MD-14/MD-15) and registration certificates
• Serve as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and delivering timely
• Respond to regulatory agency requests and obtain necessary premarket approvals, registrations, and/or licences from health authorities across the India, Asia Pacific
• Provide general support to the RA/QA department in regulatory-related matters
• Communicate with external agencies including CDSCO, TGA, SFDA, MOHAP, HSA, MDA, Philippine FDA, Thai FDA, and other health authorities with which the department interacts

What you need

• 8–14 yrs of experience
• Regulatory affairs
• Documentation
• Import/export
• PowerPoint
• Communication
• Any graduate