Regulatory Affairs Consultant- Local Regulatory Affairs Operations

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

• 7+ 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

• Manage submissions through local Health Authority portals as required

• Handle post-approval lifecycle management activities and regulatory communication-RIMS

(Regulatory Information Management Systems)-VEEVA Vault

• Support linguistic review processes including translation review and coordination

• Conduct readability testing and support artwork (AW) review, mock-ups, and approvals

• Support promotional material review including Abbreviated Product Information

 (API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)

• Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.