How to Future-Proof Your Career in Regulatory Affairs & Quality Assurance

And yet, despite widespread layoffs across life sciences in 2025, with 42,700 roles eliminated industry-wide, demand for experienced RA and QA professionals has remained resilient. Roles tied to IND submissions, CMC expertise, and global harmonisation continued to attract offers even as broader hiring stalled.

From what we see across hiring processes, the gap is not demand; it’s capability alignment.

The question is no longer whether your role will change. It’s about positioning yourself to stay relevant as the role evolves. Below are six strategic moves we see separating future-ready professionals from those at risk of being left behind.

AI is not replacing regulatory professionals. But it is changing where value sits.

The FDA launched its agency-wide generative AI tool, Elsa, in June 2025 and completed its first AI-assisted scientific review pilot the same year. In January 2026, the FDA and EMA jointly published guiding principles for AI in drug development, marking a significant step towards global harmonisation of AI use in regulated contexts.

The shift we’re seeing is clear: less emphasis on document production and more on oversight, validation, and decision-making. AI is increasingly influencing areas such as labelling, safety reporting, and even batch-release decisions.

However, many professionals are approaching AI at the wrong level. In our experience, candidates often over-index on learning AI tools, while hiring managers are prioritising those who can challenge and validate AI outputs in a GxP environment.

What to do now: Focus on AI governance, validation frameworks, and data integrity, not just tool usage. Get involved in AI implementation or validation projects, even informally. Build familiarity with the emerging FDA–EMA joint principles for AI in drug development.

The risk if you don’t: Professionals who remain purely execution-focused risk being confined to operational roles as decision-making shifts toward hybrid human - AI workflows.

The cell and gene therapy market is forecast to reach $34.3 billion by 2030, growing at 17.3% CAGR, with around 1,000 products currently in development globally. But the talent market hasn’t caught up.

We consistently see clients struggling to find RA and QA professionals with practical CMC experience in ATMPs, particularly those who have worked close to manufacturing scale-up.

Regulatory frameworks are evolving rapidly. On 1 July 2025, the EMA’s new Guideline on quality requirements for investigational ATMPs came into effect, six years in development, reflecting growing EMA-FDA convergence on CMC review. The EU’s wider pharmaceutical reform, agreed in 2025, reduces marketing authorisation assessment time from 210 to 180 days and introduces regulatory sandboxes for innovative medicines.

But complexity remains, especially in areas like comparability, donor eligibility, and process validation. And with the FDA’s own capacity now constrained by staffing losses, the quality of submissions for advanced therapies has never been more critical. Companies can expect fewer opportunities for clarification during review, meaning the regulatory professional who prepared the dossier carries even more responsibility for getting it right the first time.

What to do now: Prioritise CMC exposure within biologics or advanced therapies. Gain experience with INDs, BLAs, and lifecycle management. Build understanding across both the EMA and FDA frameworks, not just one jurisdiction.

The risk if you don’t: Many professionals have submission exposure but lack depth in manufacturing and technical development, which is where hiring demand is strongest.

The Regulatory Affairs Certification (RAC) from RAPS remains the gold-standard credential in the field. It is increasingly moving from “preferred” to “expected” for senior roles.

But the bigger shift is in hiring process behaviour. We’re seeing RAC used as an early screening filter, meaning strong candidates are often excluded before the first interview if they don’t have it.What to do now: If not certified, prioritise RAC within the next 6–12 months. If certified, ensure you’re maintaining it and consider regional or functional specialisation.The risk if you don’t: Certification is one of the fastest ways to increase both credibility and optionality. Without it, you may be filtered out of roles you’re otherwise qualified for.

A single function or single agency no longer defines the most in-demand professionals.

Across hiring processes, we consistently see demand for candidates who can operate across regulatory and clinical interfaces, navigate multiple regulatory bodies (FDA, EMA, MHRA, and others), and contribute across the full product lifecycle.

This matters more now than ever. The FDA’s staffing reductions have made regulatory interactions less consultative and more transactional, with fewer pre-submission meetings, shorter feedback cycles, and a shift from real-time dialogue to written responses. Professionals who understand how different agencies operate and can adapt their engagement approach accordingly carry a premium.

Global harmonisation is accelerating. The FDA–EMA joint principles on AI in drug development, published in January 2026, are a signal that cross-jurisdictional fluency is becoming a baseline expectation rather than a differentiator.

What to do now: Actively seek cross-functional projects like clinical–regulatory alignment, quality–regulatory interfaces. Build exposure to multiple jurisdictions, even at a supporting level. Consider lateral moves or secondments to broaden scope.

The risk if you don’t: Professionals who remain narrowly specialised in one function or one region are seeing fewer opportunities at the senior level.

A structural shift is happening in the workforce. Over 20% of professionals in pharmaceutical manufacturing and science are now aged 55 or older. 88% of organisations say succession planning is critical, yet only 19% have formal plans in place.

This creates a clear gap, and a significant opportunity. The professionals progressing fastest are not just technically strong. They are the ones who can translate complexity, lead cross-functional teams, and influence decision-making.

With regulatory environments becoming less predictable on both sides of the Atlantic, the ability to communicate regulatory impact to non-specialist stakeholders, boards, investors, and commercial teams is now a core leadership competency rather than a soft skill.

What to do now: Develop project and stakeholder management skills. Position yourself as someone who can communicate regulatory risk and strategy to non-specialists. Take ownership of cross-functional initiatives, even without formal authority.

The risk if you don’t: Many professionals wait until they are “ready” for leadership. Hiring managers are selecting those already demonstrating it.

The talent shortage in RA and QA is real, particularly at the 3–6 year experience level. Employment in medical science is projected to grow 11% by 2033, well above average, but supply is not keeping pace. As a result, we’re seeing salary increases of up to 10% in key European markets.

But the headline numbers don’t tell the full story. The biggest salary inflation is happening in the mid-level bracket, where demand is highest, and talent is scarcest. Many professionals in this range are undervaluing themselves by €10–20k.

Salary Benchmarks: Europe 2026

A recent survey found that 42% of regulatory affairs professionals are considering changing jobs, up sharply from 26% in 2024. If you haven’t explored the market in 12–18 months, you may be both underpaid and unaware of how your skillset aligns with current demand.

What to do now: Benchmark your salary against current market data, not internal assumptions. Reassess your position if you haven’t explored the market recently. A specialist recruitment partner who works exclusively in life sciences can give you an honest, data-driven view of your options.

The risk if you don’t: In a fast-moving market, staying static often means falling behind both in compensation and opportunity.

Regulatory and QA professionals are not bystanders in the transformation of life sciences. They are central to it.

The market is sending a clear signal: AI is shifting where value sits. Advanced therapies are redefining regulatory complexity. FDA capacity constraints are raising the bar for submission quality. Leadership gaps are accelerating progression timelines. And demand for the right skillsets continues to outpace supply.

Those who invest strategically in AI governance, advanced therapy expertise, global regulatory exposure, recognised certification, and leadership capability will find themselves in a position of increasing leverage.

Those who don’t risk being outpaced by a rapidly evolving market.

If you want a clear, data-driven view of how your profile compares to the current market, including demand for your skillset, salary positioning, and where you’re most competitive, we can help.

We work exclusively with Regulatory Affairs and Quality Assurance professionals across life sciences, supporting career moves at every stage.

Whether you’re actively exploring new opportunities or simply want to understand your options, we’re always open to a confidential conversation