Welcome to Next Phase Recruitment! We are very experienced in helping people to progress their careers in Reg Affairs. Firstly, here is a general guide to a career path in this sector. Please also scroll further down the page to see and apply for our current jobs that match your search criteria. We also invite you to go to the main page of our website for a broader job search and call us on 01403 216216 for a confidential discussion about your career options.
Regulatory Affairs
Regulatory Affairs professionals are responsible for ensuring that all documentation relating to the licensing, marketing and legal compliance of pharmaceutical and medical products complies with relevant legislation. The Regulatory Affirs role requires knowledge of scientific, legal and business issues.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA)
A new pharmaceutical product can take many years from inception to launch and a regulatory affairs officer will be involved from the start. The Regulatory Affairs Officer has very wide ranging responsibilities which include keeping up to date with international legislation, guidelines and customer practices; collecting, collating and evaluating scientific data; writing applications for new product licences and licence renewals as well as product labels and patient information leaflets; advising colleagues and senior management on regulatory requirements and liaising and negotiating with regulatory authorities to gain market authorisation for the company’s products.
Skills and Experience required for a craeer in Regulatory Affairs
First degree in a life science or other relevant science
Higher degree in Regulatory Affairs (e.g. MSc offered by The Organisation for Professionals in Regulatory Affairs (TOPRA)
Detailed understanding of regulatory affairs and the drug development process
Knowledge of legislation governing the approval of products
Understanding of both legal and scientific issues
Ability to assimilate data from a variety of scientific areas
Excellent communication skill, both written and oral
Experience in Regulatory Affairs, drug development, pharmaceuticals, manufacturing, clinical trials or other relevant business area
Salary Levels
Typical starting salaries range from around £20,000 to £27,000 while experienced senior Regulatory Affiars managers/directors can earn £60,000 - £80,000 and above.
South East England
South East England is one of the nine official regions of England. It consists of Berkshire, Buckinghamshire, East Sussex, Hampshire, the Isle of Wight, Kent, Oxfordshire, Surrey and West Sussex. Greater London is usually considered as a separate region, although it too is obviously located in the South East, bordering Kent, West Sussex, Surrey and East Sussex.
Major towns and cities in the South East of the UK include Brighton and Hove, Canterbury, Chichester, Oxford, Portsmouth, Southampton, Winchester, Crawley, Reading, Milton Keynes, Horsham, Farnham and Worthing. The South East of the UK is an economic hub and is second only to London in terms of its economy thanks in part to the location of Gatwick Airport in West Sussex and numerous Channel ports on the Kent coast.
Many global companies have their UK Headquarters in the South East of the UK, including a concentration of technology companies along the “M4 corridor” and numerous technology, clinical research, pharmaceutical, biotech, life science and engineering companies are located in the various counties comprising the South East of the UK.
The 'golden triangle' is the world-leading life sciences cluster of London, Oxford, Cambridge and England's greater south east.
This region is a hotbed of innovation, home to:
Four of the world's top 10 universities
Five our of seven of the UK's academic health science centres
Leading medical research institutes including hte Wellcome Trust, the Medical Research Council, Cancer Research UK, and the national Cell Therapy Catapult, focusing on stem cell research and industrialisation.
The golden triangle is being boosted further by a wave of significant new investment, including:
The Francis Crick Institute - bringing together 1,500 scientist under one roof
Imperial West - co0locating researchers and businesses on 25 acres.
UCL East - a cross-discipline enterprise and innovation centre focused on health and biological technologies on the site of Queen Elizabeth Olympic Park.
The Institute of Cancer Research - creating the world's second largest cancer research campus in south London.
AstraZeneca's Global R&D Centre - bringing together 2,000 employees in Cambridge.
South-East England is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in the South East, scientific careers in the South East or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inthe South East, give our Next Phase team a call. The London area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in London, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the area.
