Regulatory Manager / Senior Regulatory Manager
Descrizione dell'offerta
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 t
Dettagli
- Azienda: Precisionmedicinegroup
- Sede: Remoto
- Tipo di contratto: Tempo pieno
- Fonte: arbeitnow
- Valido fino al: 22 ottobre 2026
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