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.
Kent
Kent is a county in South East England, to the south east of London. Major towns and cities in Kent include Canterbury, Sevenoaks, Maidstone, Ashford, Folkestone, Tonbridge, Tunbridge Wells, Dartford, Gravesend, Sittingbourne, Faversham, Deal and Dover. France, which on a good day, can be seen clearly from Folkestone and the White Cliffs of Dover, lies across the Channel and is easily reached by regular ferry services from ports including Dover and Folkestone.
Kent has a very diverse economy with major industries including haulage, logistics, tourism, technology and scientific research. With its good transport connections many people also commute into London. Tourist attractions in Kent include Canterbury Cathedral which has been the seat of the Archbishop of Canterbury since the 6th century, HM dockyard Chatham and numerous castles.
Famous people born in Canterbury: Orlando Bloom and Mick Jagger, musician.
Kent's life sciences sector has created some of the most revolutionary and world-renowned medicines in existence.
Pfizer, Mylan, Diasorin, Smiths Medical and over 450 other life science sector companies have made Kent their home over the years, putting the country on the map as a key location for everything from bio-tech, pharmaceuticals and diagnostics to global science logistics, med-tech manufacturers and contract research organisations.
Kent is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Kent, scientific careers in Kent or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Kent, give our Next Phase team a call. The Kent 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 Kent, 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 Kent area.
