The life sciences industry continue to face unprecedented challenges and increasing regulatory scrutiny. Globalization, increasing transparency expectations, accelerated digitalization, and constant evolving needs of customers are key factors that are impacting companies’ approach to regulatory and compliance.
The Life Sciences industry has seen record levels of investment in recent years for a variety of reasons. New investment yields new products, which all require regulatory approval. Therefore, more talent is in need to support the rapidly evolving regulatory environment, while in reality, we don’t have enough regulatory and compliance talent for a few years now.
The Regulatory Affairs and Compliance global market is expected to grow up to $30 billion by 2030. There is huge expected growth in medical devices, although drugs and biologics also contribute to the upward growth trend in the areas of Oncology, Cardiology, Neurology and Immunology.
The regulatory agencies are going through technological and scientific innovation, and ultimately it impacts patients positively by pushing up standards of new treatments and data accuracy.
Regulatory and compliance professionals play a critical role in a life science company, from product development, approval and distribution, to inspections, audits and non-compliance issues. It is not an area in which you want to be short staffed but it is often times in reality not the case.
In the world of Regulatory Affairs, it is in the field of medicines/vaccines that there is the greatest demand for specialists. The pandemic triggered a surge in requests for evaluation of vaccines and to get them to market as quickly as possible. The Regulatory Affairs specialists with two to three years of experience, and the Regulatory Affairs Managers with more than five years of experience are in high demand. This high demand for specialists is pushing more and more companies to allow these specialists to work remotely in order to attract more talent from a broader talent pool. At the meantime, more and more candidates are also choosing to freelance instead of working for a company given better rates available and more flexibility with their life arrangement. Therefore, life science companies and good recruiters must come up very creative and enticing offers in order to win talent in this market.
Most of the life science companies retain the knowledge of regulatory frameworks, requirements, legislation and processes in house. When sourcing and interviewing candidates, soft skills are increasing in demand in the area of detail orientation, communication, prioritization, multitasking and system thinking.