Descripción de la oferta
Overview
In this role you drive regulatory leadership for clinical trial approvals and lifecycle activities, focusing on EU CTR and CTIS processes. You’ll work within a cross-functional team to shape submission strategies, manage interactions with authorities, and ensure compliant documentation. You’ll mentor juniors, support business development, and help optimize regulatory processes. This is a strategic, client-facing role at a global CRO leader dedicated to accelerating safe, compliant trials.
ResponsabilidadesAct as Regulatory Global Team Leader for regulatory projects or Regulatory Project Manager for stand-alone projectsLead preparation, review, and submission of regulatory documentation with compliance and qualityProvide strategic regulatory advice to clients including EU submission strategy, RMS selection, and lifecycle managementLead and support EU CTR submissions including initial CTAs, substantial modifications, RFIs, and CTIS lifecycle activitiesManage communications with regulatory authorities and support agency meetingsBuild and maintain client relationships as a trusted regulatory advisorOversee project timelines, deliverables, budgets, and out-of-scope activitiesMentor juniors, review regulatory documentation, and support professional developmentSupport business development including bid defense meetings and client presentationsContribute to SOPs and cross-functional regulatory initiatives and process improvementsStay current with regulatory intelligence and evolving regulationsPerform additional duties to support business and departmental objectives
Requisitos principalesMinimum 8 years of regulatory affairs experience in pharma, biotech, or CROMinimum 2–3 years of hands-on EU CTR and CTIS experience with CTAs and lifecycle activitiesExperience interacting with RMS and other European regulatory authoritiesProven ability to advise on EU regulatory strategy including RMS selection and submission planningAdvanced understanding of EU clinical trial regulations and CTIS requirementsStrong understanding of regulatory documentation across therapeutic areas and product modalitiesProject leadership and stakeholder management skillsExcellent written and verbal communication for regulatory documents and client-facing presentationsProficiency in Microsoft Office and regulatory publishing toolsApplicable certifications and licenses as required by local regulationsWillingness to support global initiatives and cross-functional workleadershipclient relationship managementexcellent written/verbal communicationEU CTR submission strategyCTIS lifecycle management (RFIs, substantial modifications)Regulatory documentation and publishing
