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 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
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.