Connecting...

Banner Default Image

Welcome to Next Phase Recruitment! Please see below our current jobs that match your search criteria. For a broader job search please visit the home page or call us on 01403 216216 to discuss career options in other areas of Life Science and Technology.

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.

Stevenage

Stevenage is a town in Hertfordshire approximately 35 miles north of London.  Although there is evidence of a Roman settlement, Stevenage grew very slowly over the centuries.  However, in 1946 Stevenage was designated Britain’s first “New Town” which meant six neighbourhoods being developed to help resolve the UK’s post-war accommodation problems.  Opened by the H.M. the Queen in 1959, Stevenage's pedestrianised town centre was the first traffic free shopping zone in Britain.   From a business point of view, Stevenage has become a centre for Life Sciences thanks to the Stevenage Bioscience Catalyst which aims is to support the next generation of pharma and biotech companies by offering  access to equipment and facilities and in so doing placing the UK bioscience sector at the forefront of worldwide biomedical innovation.  More recently Stevenage has become famous for the annual rock and pop festival held at Knebworth.

Famous people born in Stevenage:  Lewis Hamilton,  F1 motor racing world champion and Ian Poulter, professional golfer