Regulatory Affairs Manager

Recruiter
Quotient Clinical Limited
Location
Nottingham
Posted
10 Aug 2017
Expires
15 Sep 2017
Company Overview Our growing and successful business comprises of over350 talented individuals in an environment where everybody counts and is instrumental to our success. People join Quotient Clinical 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 abouthelping our customers get new medicines to market. Learning and development is at the heart of our culture at Quotient and you will be given every opportunity to reach your potential with us. You'll be recognised for your contribution and rewarded with genuine career development, a competitive salary & a whole host of benefits. The Role This is a fantastic opportunity to join our growing Regulatory Affairs team as a Regulatory Affairs Manager. In this role you will be responsible for the preparation coordination and submission of regulatory applications (CTA, Ethics and ARSAC) as well as ensuring that the quality of these submissions is maintained as appropriate throughout the lifespan of the study. As a Regulatory Affairs Manager you will act as the regulatory lead for studies within a wider project specific team, providing regulatory advice on submission strategy within Quotient Clinical, as well as regulatory advice and guidance to Quotient Clinical and clients as required. You will be responsible for reviewing Quotient Clinical and client submission documentation and dealing with all post-submission activities including responding to questions from the authorities. You will create and review regulatory submission documents such as IMPDs. and IBs and will also be responsible for the preparation of ARSAC certificate applications where required. Throughout this process you will act as the primary regulatory point of contact and interact directly with the authorities as required. The Candidate The ideal candidate would be educated to degree level in a science subject and possess a minimum of 3-4 years regulatory affairs experience within the pharmaceutical industry. In addition, the candidate would be able to demonstrate a comprehensive understanding of drug development, the regulatory application and submission process and adhere to legal obligations where required. You should also have: Strong written and verbal communication skills and possess the ability to liaise and negotiate with the regulatory authorities (including the MHRA, Ethics Committees, ARSAC) and clients where required; Have experience of the interpretation of regulations, guidelines and policy statements; Demonstrate strong project management skills including planning, prioritisation, problem solving, decision making and adherence to strict deadlines; Convey and present complex information to others clearly and logically; Work independently and manage their own workload; Work effectively on an number of projects simultaneously; Work to a high quality standard and possess a high level of attention to detail; Be a good team player building constructive relationships both throughout the company and externally Have a working knowledge of GCP. Applicants must have the right to work in the UK upon being offered employment. In return, you will join a dynamic team with an exciting career ahead of you within a well-established and successful drug development company. Company benefits: As well as offering ongoing training,we offer flexible working, private healthcare and life assurance, 33 days holiday (inclusive of bank holidays) & group pension plan. We have various recognition and appreciation schemes in place to say Thank you' to our staff for all their hard work e.g. employee of the quarter, food treats and staff parties. We provide a subsidised restaurant and have free parking at our site in our leafy surroundings just outside Nottingham.