Senior Regulatory Affairs Associate- Local Regulatory Affairs Operations

Overview

Manage post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements.

What you'll do

• Manage post-approval regulatory lifecycle activities and regulatory communication in RIMS-Veeva Vault.
• Partner with cross-functional teams to ensure timely regulatory submissions and maintain regulatory dossiers.
• Prepare and coordinate Module 1 activities (including CMC, Safety, Administrative, MA transfers, Article 31, and other post-approval variations and MAAs).
• Support DHCP (Direct Healthcare Professional Communication) activities and commit follow-up.
• Manage submissions through local Health Authority portals as required.
• Support linguistic review, readability testing, and artwork (AW) review, mock-ups, and approvals.
• Support PSUR submissions and country-level regulatory intelligence activities.

What you'll need

• 4+ years of experience supporting regulatory submissions, including MAAs, variations (minor/major), question responses, renewals, withdrawals, and marketing authorization transfers.
• Working knowledge of EU procedures, including centralized procedures coordination and management.
• Experience preparing and coordinating Module 1 activities for relevant post-approval regulatory work.
• Experience using regulatory systems including RIMS (Regulatory Information Management Systems) and Veeva Vault.
• Ability to coordinate translation review as part of linguistic review processes.
• Experience supporting promotional material review, including API creation or updates and UK pre-vetting.