Regulatory Affairs Manager or Associate Director

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 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: Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs; Maintaining timelines for full regulatory submissions; Providing regulatory advice and guidance to other departments to ensure compliance with EMA regulations and requirements; Interaction with EMA and other regulatory agencies; Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA; and Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges Requirements: Bachelor’s degree and significant regulatory affairs experience; CMC experience preferred; 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); and Must be a team player with a global regulatory mindset. This position may require supervision of junior level staff. This Regulatory Affair Manager or Associate Director 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/89632010

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