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Responsibilities
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 Responsibilities7+ 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-upManage submissions through local Health Authority portals as requiredHandle post-approval lifecycle management activities and regulatory communication-RIMS (Regulatory Information Management Systems)-VEEVA VaultSupport linguistic review processes including translation review and coordinationConduct readability testing and support artwork (AW) review, mock-ups, and approvalsSupport 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.Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™
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