The event on the future of the Regulatory Affairs professional, organized by Sindusfarma and RAPS Brazil on October 1, 2026, was an excellent opportunity to reflect on regulatory careers in the pharmaceutical industry. Over an intense morning, leaders from the pharmaceutical and medical device industries, along with ANVISA directors, shared their career paths, lessons learned, and views on where the profession is heading. The sense conveyed throughout the talks is that we are living through a turning point, one that demands a much more active stance from these professionals than the field has traditionally taken.

An event built on career paths

The program followed a well-thought-out line: it started from a broad view of the evolution of the Regulatory Affairs role and of the professional of the future, moved through the diversity of roles that regulatory can take on, dove into change management, and ended with the health authority’s perspective.

Marcos Paulo Moreira, Regional Regulatory Affairs Lead for Latin America at MSD, spoke about the future of the regulatory professional and his own career, which spanned areas such as manufacturing, quality, regulatory policy, human resources, and an integration between companies before reaching regional leadership, which is in itself a portrait of how broad training enriches regulatory work.

Patrícia Gomes Silva, Regulatory Affairs Manager at Johnson & Johnson MedTech, approached the topic from a technical perspective that evolved over the years and reached the strategic layers of companies, covering the various faces of Regulatory Affairs professionals, drawing on nearly two decades in the medical device universe and strong engagement with authorities and sector associations.

Beatriz Fernandes, Global Director of Change Management and Communication in Regulatory Affairs at AbbVie, presented her perspective on change management, considering a future that promises many changes. A pharmacist and psychologist with more than 30 years in the sector, she brought a deeply human approach to getting through transformations.

Finally, Daniela Marreco, Director of ANVISA’s Second Directorate, and Marcelo Moreira, Substitute Director of the Third Directorate, shared some of their professional journeys and the authority’s view of the new regulatory professional.

Change is the only constant

All the talks, in one way or another, came back to this point. The regulatory profession has developed amid deep transformations: technological advances, new ways of working, and extremely dynamic regulations that demand continuous updating. And nothing suggests that this pace will slow down. On the contrary, the future promises even more advances, especially in technology.

This scenario was presented not as a threat, but as the very nature of the profession. Those who choose to work in Regulatory Affairs choose, in a way, to live with permanent change. The question is not whether things will change, but how professionals are preparing to lead those changes rather than merely react to them.

From “paperwork collector” to regulatory scientist

The strongest reflection of the day was about the evolution of this professional’s identity. For a long time, the regulatory professional was seen, and in many cases acted, as a “paperwork collector”: someone responsible for gathering documents, assembling dossiers, and filing submissions, with little room for analysis.

That profile is a thing of the past. Today we talk about regulatory science, a discipline that requires scientific rigor, critical analysis of documentation, and the ability to interpret data in light of new technical requirements and the regulatory context. The professional has moved from being a task executor to someone who evaluates, questions, recommends, and influences.

This change in nature came with a change in position. Regulatory became a strategic area, one that sits at the board table and takes part in business decisions. In this sense, regulatory strategy can determine a product’s time to market and the feasibility of launches.

The competencies that will define the professional of the future

Over the course of the presentations, a set of competencies took shape that may form the profile of the regulatory professional in the coming years.

• Data analysis and artificial intelligence. Technology is already transforming how work gets done, and the trend is for automation and AI tools to take on a growing share of operational activities. But there was one essential point of consensus: AI can accelerate, organize, and suggest, but the final version, the one that takes on the commitment to the company and the authority, is human. It is necessary to master the tools without outsourcing our critical judgment to them.
• Strategic vision and early involvement. Regulatory can no longer be called in only at the end of the process, when the product is ready for the marketing authorization application. The area’s value should show up from the early stages of development, helping to build the regulatory strategy alongside the product itself, anticipating risks, identifying more efficient pathways, and avoiding deficiency letters and rework. In addition, the professional must know how to distinguish what is non-negotiable and admits no flexibility, and it is their duty to defend it firmly; but there is also room to propose alternatives and build solutions that reconcile compliance and business objectives.
• Technical knowledge with accessible communication. Knowledge must be translated for those outside the field: research, marketing, quality, legal, senior leadership, and authorities, often in international contexts, combining technical depth with clear, intercultural communication.
• Agility to learn. In an environment where regulations, technologies, and ways of working change all the time, the ability to learn quickly, and to unlearn when necessary, may be the competency that sustains all the others.

Industry and authority in the same conversation

One aspect that made the event special was the atmosphere. The environment was very relaxed, and the speakers, including the ANVISA representatives, were quite at ease talking about their experiences and career paths. Seeing authority directors share their views with this openness reinforces something fundamental for the future of the field: building a more collaborative regulatory environment, based on dialogue, transparency, and mutual trust among companies, authorities, and professionals.

The packed auditorium also says a lot. It shows that the regulatory community is mobilized, interested in discussing its own future, and willing to prepare for it.

This is a very interesting time to be a Regulatory Affairs professional, with the area gaining relevance, prominence, and complexity and, at the same time, greater responsibility.

It is not enough to keep up with changes: one must develop the competencies that make it possible to lead them. Technology will keep advancing, regulations will keep evolving, and challenges will keep renewing themselves. What will set the professional of the future apart is the ability to combine scientific rigor, strategic vision, human sensitivity, and a willingness to always keep learning.

Congratulations to Sindusfarma, RAPS Brazil, and all the speakers for providing such a rich morning of content and exchange of experiences.