Regulatory Affairs Associate- Local Regulatory Affairs Operations

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.

Benefits

Additional Information

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.

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Company Intel

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