We are currently looking for a Senior Regulatory Affairs Associate (CTA Lead) who will be accountable for leading operational submissions execution for designated CTAs. You will operate as a regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. This is a client-dedicated role- you will partner with one of our key clients.
Role Responsibilities: Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines. Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct. Responsible for the co-ordination of translations for core documents required for submission Manages the compilation for core package build, contributing to CTA and authoring documentation as required Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. Discussed with relevant SMEs the interpretation of dossier requirements QualificationsSkills & Experience BS/BSc in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered. Experience in Regulatory Affairs and Clinical Research (3+ years) In-depth understanding and proven execution of CTA and Central Ethics processes globally Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards Fluency in English is a must (any additional European languages are a plus) You will be rewarded with a competitive salary and benefits package! And we can offer extensive career development within our growing Regulatory portfolio
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.