Regulatory Affairs Manager or Associate Director (ATMP/GMO)

Skills Alliance Limited ,
London, Greater London
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Overview

A Leading global full service CRO are currently recruiting for a Regulatory Affair Manager or Associate Director (ATMP / GMO) in their London offices. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability. They work in a range of area specialising in Oncology, Cardiology, Metabolic diseases and many more. Responsibilities: Project management focus to facilitate full global regulatory submissions, which will include: Develop and review regulatory submission documents in support of clinical trials with a specific focus in providing Advanced Therapy Medicinal Products (ATMP)/ Genetically Modified Organisms (GMO) advice and dossier compilation; Developing, tracking, compiling, and maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs); Maintaining timelines for full regulatory submissions; Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with UK and European regulations and requirements; Developing scientific and regulatory briefing documents for meetings with the EMA; Interaction with EMA, MHRA, and other regulatory agencies; Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges. Requirements: Bachelor’s degree and demonstrated regulatory affairs experience; Knowledge of Advanced Therapy Medicinal Products (ATMP) is essential with Genetically Modified Organisms (GMO) experience being highly desirable; Experience with EMA and other regulatory agencies is preferred; Strong computer skills, project management skills, and a high attention to detail; Strong communication skills (both written and oral); Must be a team player with a global regulatory mind-set; This position may require supervision of junior level staff. Travel: Less than 30% This Regulatory Affair Manager or Associate Director (ATMP / GMO) position is a permanent role offering a highly competitive salary benefits. Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW This job was originally posted as www.totaljobs.com/job/89648348

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