Regulatory Manager / Senior Regulatory Manager

Precisionmedicinegroup·RemoteRemotosenior

En corto

→Gestiona estrategias reguladoras para ensayos clínicos en oncología y enfermedades raras.
→Prepara y coordina presentaciones regulatorias a agencias y comités éticos con enfoque en designaciones de orfandad y procedimientos acelerados.
→Destacado: Trabajas en un CRO innovador que integra ciencia, datos y ensayos clínicos en tiempo real.

Fluency in English required

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¿Qué piden?

✓Experiencia comprobada en regulación de ensayos clínicos en oncología o enfermedades raras.
✓Conocimiento sólido de requisitos regulatorios en EU, UE y regiones clave.
✓Capacidad para liderar documentación de presentación a agencias reguladoras.
✓Experiencia en gestión de solicitudes de designación de orfandad y planificación pediátrica.
✓Habilidades de comunicación efectiva con equipos multidisciplinarios.
✓Capacidad para supervisar y guiar a especialistas en regulación.

¿No cumplís todo? Es lo normal — tu dossier gratis te dice qué gaps tenés y cómo cubrirlos en la entrevista.

CTA/INDAnnual ReportsAmendmentsScientific AdviceRegulatory Authority MeetingsOrphan DesignationsPaediatric PlanningMarketing ApplicationsRegulatory SubmissionsRegulatory Intelligence Tools

¿A quién escribirle en Precisionmedicinegroup?

Tu dossier gratis identifica a las personas que te entrevistarían — con su background, qué valoran y cómo escribirles para destacar antes de aplicar.

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team. As a Regulatory Manager, you will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Essential functions of the job include but are not limited to: • Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required <li style=

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