The current state of (regulatory) affairs Viewpoint careers advice blog

The current state of (regulatory) affairs Uncertainties and change have become the new normal within the life sciences sector, and this is impacting on the regulatory environment. A feature common to all regions is the tightening of regulation in the pharmaceutical, biotech and medical devices industries. In forthcoming episodes of this series, we plan to explore the impact of regulatory changes and pressures on company operations and talent trends. Embracing the reality of change The life sciences industry is in a period of intense transformation, as the Hays Life Sciences Salary Guide and Market Overview 2014 highlights: “As science constantly evolves, new and innovative therapies are coming through the pipeline. The need for strong scientific regulatory professionals is paramount to ensure this next generation of products reaches patients, through current and future regulatory models.” The life sciences industry is traditionally considered to be a stable and highly profitable business. However, recent years have been characterised by considerable turbulence. The economic crisis, the expiry of major patents and hard questions about the safety of drugs have contributed to this climate of uncertainty. Many analysts also consider that the industry is moving from the era of ‘the blockbuster drug’ to a new development model â€" the era of ‘personalised medicine’. The implications could be seismic. Companies that are bringing medicines to market already face complex issues, and the regulatory environment is a key component in every stage of this process. No matter where in the world you look, these processes are under increased pressure, with a greater scrutiny of operational and research practices and a trend towards the centralisation of marketing, development and safety standards. Phu Huynh, Senior Recruitment Consultant specialising in regulatory affairs and quality assurance for Hays Life Sciences in North America, describes the situation in the USA, which is echoed in Europe under the European Medicines Agency (EMA): “Gaining FDA approval for new drug and biologics licence applications [NDAs and BLAs] is becoming increasingly difficult and, in turn, there is an increased need for skilled regulatory affairs professionals, who can overcome such obstacles by developing innovative regulatory pathways to achieve market approval.” Underlying financial pressures have also led to rapid changes in business structure for many companies, including outsourcing of research and development to local providers and relocation of manufacturing bases to countries like China and India. This has created instability, new types of roles and a shrinking of permanent positions. There has been a bias towards contract work and a high demand for versatility and specialised skills in regulatory affairs. In Europe, recent changes in pharmacovigilance legislation announced by the EMA have certainly impacted on regulatory roles. In particular, pharmaceutical companies are being obliged to invest in contractors or consultancies to ensure their regulatory submission management systems are compliant with EudraVigilance Medicinal Product Dictionary (EVMPD) and Extended EudraVigilance Medicinal Product Dictionary (xEVMPD) standards by the end of 2014. Companies are also seeing the value of keeping ahead of proposed changes in EU legislation and investing in permanent headcount accordingly. There is calm emerging after the storm As economic conditions improve, companies are beginning to identify and exploit new commercial opportunities and new positions are becoming available. Roles are emerging in areas such as post-approval regulatory affairs for high volume off-patent drugs and development of biosimilars. These evolving business areas are reviving demand for permanent roles, opening up new directions and improving prospects for candidates across the board, as Hays’ guide explains: “In an about-turn from the job-cutting days of the late noughties, vacancies for permanent roles [in regulatory affairs] are now increasing in all areas (pharma, biotech, generic and consumer medicines, medical devices) and at management levels.” The industry as a whole is now being challenged to move beyond crisis management and implement a strategic approach that builds solid, reliable compliance structures under the revised business conditions. A career in regulatory affairs Positions in regulatory affairs are, generally, well remunerated. A career in the field revolves around ensuring the safety and efficacy of medicines, and usually requires a life sciences degree with a Masters or PhD. Hays Life Sciences is a leader in recruitment to the pharmaceutical, biotech and medical devices industries and is dedicated to filling vacancies for regulatory affairs jobs worldwide. We offer specialist services designed specifically to match the right talent to the right position. This includes global searches, for which we provide both recruitment insight and guidance with regard to visa applications and immigration issues. Be part of the conversation. Join our Life Sciences Industry Insights LinkedIn group to share your thoughts and stay up-to-date with the latest life sciences employment and recruitment news. Join the conversation