Study Start Up & Regulatory Manager

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Company Overview Our growing and successful business comprises of over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money. People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market. The Role Quotient Sciences has an exciting career opportunity for a Study Start Up & Regulatory Manager in our UK Regulatory Affairs team. In this role, you will lead on Regulatory start up projects. You will be ultimately responsible for leading and coordinating assigned duties to enable study start up for phase 1 clinical studies at our clinical trials unit in Nottingham. Main tasks and responsibilities include: Leading and coordinating Regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) Authoring and review of clinical documentation prepared for submission Compile and submit applications and perform maintenance activities throughout the lifecycle of a clinical study conducted at Quotient Sciences Drive continuous quality improvement initiatives relating to regulatory submissions, Ethics, and ARSAC submission processes Act as point of contact for Regulatory Authorities This role comes with fantastic career development opportunities. If you would like to join a fast paced and dynamic business and make a difference in early phase drug development, then this is the role for you. This is a UK home based role, with occasional travel to our site in Nottingham. The Candidate The successful candidate will be educated to a minimum degree level in a biological or life science discipline, coupled with previous regulatory experience in a similar study start up role in a pharmaceutical company or CRO. Experience of US IND and eCTD submissions is also desirable although not essential. Other skills and experience required: Possess detailed knowledge of relevant regulations & guidance and ability to critically analyse and apply knowledge to develop innovative regulatory solutions to arising issues Proven project leadership and team work ability Ability to juggle a range of tasks/ issues simultaneously Ability to work to strict and tight deadlines Possess high quality standards and attention to detail Be a confident and articulate communicator (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically Demonstration of effective communication with regulatory authorities Being customer focused and ability to respond to sponsor requirements Company benefits In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business. This job was originally posted as www.totaljobs.com/job/91718697

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