Regulatory Manager / Senior Regulatory Manager

Precision Medicine Group

Poland

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

Requisitos

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. Responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. 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 m

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