Manager - Regulatory Affairs (New Product Registrations)

About the role

Responsible for leading Regulatory Affairs individuals accountable for management of new product registration activities in international markets that include compilation, review & submission of new product registration dossiers, deficiency responses and pre-launch variations etc. Perform due diligence and help cross-functional teams in planning, prioritizing & tracking of planned dossier dispatches/submission and launches respectively.

What you'll do

• Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met
• Review, compile and dispatch new product submissions and pre-launch variations
• Handling of deficiencies received from Affiliates and/or customer and health regulatory agencies on the new product submissions and pre-launch variations
• Ensure documents are of high-quality standard to meet one cycle review from Regulatory authorities
• Review submission and / or approval notifications for new product applications submitted to Regulatory agencies

What you need

• 15–27 yrs of experience
• Regulatory affairs
• MS Project
• Communication
• Due diligence
• Any graduate