New global survey maps 2025 reality for the FDA (not only) Regulatory Affairs professionals

NEW YORK - Aug. 13, 2025 - PRLog -- A new peer-reviewed study by Dr. Vlad Reznikov analyzes responses from 574 regulatory affairs (RA) professionals from Life Science companies across six continents, offering a clear snapshot of the profession's pressures and priorities in 2025. The research—spanning pharmaceuticals, medical devices, and biotechnology—examines four domains: professional relationships and workflow, quality management and the "middleman" issue, competition/compensation, and the impact of AI.

Key insights include a persistent friction in day-to-day engagement with national regulatory authorities and internal stakeholders; strong organizational emphasis on quality paired with resource and timeline constraints; and widespread concerns about compensation, career progression, and an increasingly competitive job market. Notably, respondents express a decisive preference for direct, transparent collaboration: 92% favor working without intermediaries when quality systems are comparable, and 98% would participate in a transparent RA marketplace model enabling direct client engagement and equity-based incentives.

Technology is viewed as both a catalyst and a challenge. About two-thirds expect AI to significantly reshape RA roles within five years, while calling for practical training, clear governance, and safeguards for data integrity. To validate consistency across ordinal measures, the study uses Stuart's τc (Kendall's tau-c), demonstrating strong internal reliability of key scales.

"This survey captures options to significantly reduce a Healthcare R&D costs worldwide, eliminating a 'middleman' predator behavior by replacing it with AI-powered CRM and QA. Our profession is in transition—seeking clearer communication, fair recognition, and smarter tools, without compromising quality or ethics," said Dr. Vlad Reznikov.

Read the full article and results:
https://www.researchgate.net/publication/394470856_Challenges_and_Perspectives_for_Regulatory_Affairs_Professionals_in_2025_A_Survey_Analysis_and_Organizational_Dynamics_Insight