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.
Ireland's Life Sciences sector has grown rapidly from modest beginnings in the 1960s to reach global significance. Collaborative clusters in Pharmaceutical, Biotechnology, Medical Devices and Diagnostics have been a key element behind this remarkable growth in a sector that accounts for 32% of GDP.
The sector continues to develop and evolve, more recently Ireland has expanded its global hub beyond commercialisation to include innovation, digitalisation and next generation technologies.
Ireland is the 3rd largest exporter of pharmaceuticals globally.
85+ Pharmaceutical companies operate in Ireland - and it has 9 of the world's top pharmaceutical companies.
50 FDA approved pharma and biopharma plants.
Dublin is the capital and largest city of Ireland. Situated on a bay on the East Coast, at the mouth of the River Liffey, it lies within the province of Leinster. It is bordered on the south by the Dublin Mountains, a part of the Wicklow Mountains range.
Dublin is the largest centre of education in Ireland, and is home to four universities and a number of other higher education institutions. It was the European Capital of Science in 2012.
The University of Dublin is the oldest University in Ireland, dating from the 16th century, and is located in the city centre. Its sole constituent college, Trinity College (TCD), was established by Royal Charter in 1592 under Elizabeth I. It was closed to Roman Catholics until 1793, and the Catholic hierarchy then banned Roman Catholics from attending until 1970. It is situated in the city centre, on College Green, and has over 18,000 students.
The National University of Ireland (NUI) has its seat in Dublin, which is also the location of the associated constituent university of University College Dublin (UCD), which has over 30,000 students. Founded in 1854, it is now the largest university in Ireland.
As of 2019, Dublin's principal, and Ireland's largest, institution for technological education and research, Dublin Institute of Technology (DIT), with origins in 1887, has merged with two majour suburban third level institutions, Institute of Technology, Tallaght and Institute of Technology, Blanchardstown, to form Technological University Dublin, Ireland's second largest university by student population. The new university offers a wide range of courses in areas including engineering, architecture, scieces, health, journalism, digital media, hospitality, business, art and design, music and the humanities programmes, and has three long-term campuses, at Grangegorman, Tallaght and Blanchardstown.
Dublin City University (DCU), formerly the National Institute for Higher Education (NIHE) Dublin, offers courses in business, engineering, science, communication courses, languages and primary education. It has around 16,000 students.
The Royal College of Surgeons in Ireland (RCSI) conducts a medical school which is both a university and a recognised college, there are also large medical schools within UCD and Trinity College. The National College of Ireland is also based in Dublin, as well as the Economic and Social Research Institute, a social science research institute.
Ireland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Dublin, scientific careers in Dublin or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Dublin, give our Next Phase team a call. The Irish 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 Dublin, 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 Dublin area.
