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+ years' experience in supporting regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers. Europe 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 Skilled 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.
Collaborate with global, regional, and affiliate stakeholders on launches, audits, inspections, change controls, deviations, and market updates