Senior Regulatory Affairs Consultant (Clinical Trials)

Parexel Romania is currently looking for an experienced Senior Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe.

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies.

As a Senior Regulatory Affairs Consultant you will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.

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. QualificationsIdeal candidate will possess: University degree in Life Sciences. Numerous years of experience in Regulatory Affairs within Pharma or CRO is mandatory. In-depth understanding and proven execution of CTA process globally. Leadership skills. Fluency in English is a must along with the local language. Ability to work with a multinational team, focusing on multiple issues under tight timelines. Good computer skills.