Senior Regulatory Affairs Associate- 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** - 4+ 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. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.