Regulatory Affairs Associate- Local Regulatory Affairs Operations

When our values align, there's no limit to what we can achieve.
 

This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

Key Responsibilities

• 2+ yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers.

Working knowledge on EU procedures including centralized procedures coordination and management.

• Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s.

• Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up

• M...