Regulatory Affairs Consultant (Clinical Trial Application) in Bucuresti

Parexel Regulatory & Access is currently looking for a Consultant Regulatory Affairs to join the Clinical Trials Regulatory Services team in Romania as Regulatory coordinator to be part of a multi-national project team and take the lead to coordinate the compilation, review and submission of regulatory agency applications for international complex clinical trials in multiple countries. Previous experience with GMO, Medical Device studies would be an advantage.We are looking for candidates based in Romania.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. Discuss with relevant SMEs the interpretation of dossier requirements. Business Development - continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience. Communicates potential new business leads to Parexel consulting management and account managers. QualificationsIdeal candidate will possess: University degree in Life Sciences. Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO. Fluency in English is a must along with the local language. In-depth understanding and proven execution of CTA process globally. Ability to work with a multinational team, focusing on multiple issues under tight timelines. Good computer skills.You will be rewarded with a competitive salary and benefits package! And we can offer extensive career development within our growing Regulatory portfolio.2021-09-04 00:05:27


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