Regulatory Affairs Associate- Local Regulatory Affairs Operations
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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
- 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.