After a year away on maternity leave, I’ve recently returned to ARM and to the European Regulatory Affairs market. I’ve worked in recruitment for more than ten years, with Regulatory Affairs a major focus for much of that time. But a year is a long time in life sciences, so coming back has meant reconnecting with clients and candidates, and getting up to speed with what’s changed.
My focus is freelance and interim Regulatory Affairs recruitment across pharmaceuticals, biotechnology and medical devices. Three developments have stood out since I’ve been back.
EU pharma reform: are Regulatory Affairs teams ready?
The reform of EU pharmaceutical legislation is the obvious place to start. It’s been described as the most comprehensive reform of EU pharmaceutical legislation in over 20 years, covering access to medicines, competitiveness and supply.
It’s now in the final stages. Political agreement was reached in December 2025, and the Council formally adopted the package on 28 September, with Parliament’s formal approval still to come. Once the legislation is published, new requirements will phase in over transitional periods rather than arriving all at once, with full applicability expected by 2028.
So, are teams ready? It depends on the company, but few will find it simple. The rules arrive in stages, so teams will be dealing with them alongside their normal workload. Teams will need to interpret the new rules and update submissions, processes and lifecycle plans while still delivering day-to-day work. I’d expect demand for experienced Regulatory Affairs capacity to build gradually as organisations work out what the new framework means for their portfolios.
The European Biotech Act: what could it change?
Biotech is an area I’ve always particularly enjoyed working in, so the European Biotech Act is firmly on my radar.
It’s still a Commission proposal working its way through Parliament and the Council, so the details could change. The aims, though, include easing access to funding for start-ups and SMEs, making greater use of AI and data, and cutting time to market. It also looks to streamline areas such as clinical trials.
Potentially, what it changes is the pace. Smaller biotechs often run lean teams with very specific skills needed at each stage of development. If the Act makes it easier to move products forward, those businesses may need to bring in regulatory expertise sooner, and often only for a defined project. That’s where freelance specialists can add the most value.
MDR and IVDR: the transition isn’t over yet
Anyone working in medical devices knows this isn’t a new story, but it remains a live issue. Transition deadlines for legacy devices run to the end of 2027, 2028 or 2029, depending on device class, and they only apply where manufacturers have taken the required steps towards compliance. The Commission has also proposed further simplification of both regulations, which is still going through Parliament and the Council.
For manufacturers, that means a long period of juggling legacy devices, certification timelines and new submissions at the same time.
It’s also a good example of why freelance Regulatory Affairs expertise makes sense. A business might need someone with very specific experience to support a transition, work through a notified body process or add capacity at a demanding point, without needing that resource permanently afterwards. Bringing in the right specialist at the right time is one of the things I enjoy most about the contract market.
A year away, plenty to come back to
Regulatory Affairs sits at the heart of some significant changes across pharmaceuticals, biotech and medical devices. Over the coming months I’ll be sharing more on the developments I’m following and what they could mean for teams and professionals in the sector.
For now, it’s great to be back.
If you’re looking for freelance or interim Regulatory Affairs expertise in Europe, or you’re a Regulatory Affairs professional interested in your next project, I’d love to reconnect.
Jasmine is Lead Regulatory Consultant at ARM. Find out more about ARM’s Life Science recruitment capability across European Regulatory Affairs market, or connect with Jasmine directly on LinkedIn.
Sources
European Commission: European Biotech Act
European Commission: Medical devices, new regulations (including the December 2025 targeted revision proposal)
EUR-Lex: Commission proposal on MDR/IVDR simplification
European Medicines Agency: Reform of the EU pharmaceutical legislation
Council of the EU: Pharma package, Council and Parliament reach a deal (11 December 2025)
Jasmine Smith
Lead Regulatory Consultant
