Regulatory operations leader Ilona Barskaya launches Votum Consulting

Ilona Barskaya, managing partner of Votum Consulting LLC, is advising pharmaceutical and biotechnology companies on regulatory operations, systems and submissions after nearly two decades in life sciences. Her profile highlights a career spanning Genentech/Roche and MyoKardia, plus a focus on helping teams manage AI-driven change, compliance demands and faster development timelines. Why it matters: - Regulatory operations is becoming a pressure point for pharma and biotech as companies face faster drug development timelines, more complex submissions and new AI tools. - Barskaya’s work centers on helping organizations build scalable regulatory infrastructure that supports compliance, efficiency and patient access to therapies. - Her consulting model targets small and mid-sized life sciences companies that need enterprise-level regulatory capabilities without the overhead of a large in-house team. What happened: - Ilona Barskaya is the managing partner of Votum Consulting LLC, a regulatory operations consulting firm based in Burlingame, California. - Barskaya is profiled as a regulatory operations expert and biotech advisor with nearly two decades in the life sciences industry. - Her career includes roles at Genentech/Roche, where she advanced from an entry-level position into senior leadership. - She later joined MyoKardia to build and lead the Regulatory Operations function from the ground up. - Barskaya now works with pharmaceutical and biotechnology companies on regulatory strategy, system implementation, submission execution and process transformation. The details: - At Genentech/Roche, Barskaya led global regulatory operations teams and managed complex submission portfolios. - Her work at Genentech/Roche also included workforce planning, outsourcing models and large-scale operational improvements. - At MyoKardia, Barskaya defined the regulatory infrastructure strategy and implemented enterprise systems, including Veeva RIM. - She guided the company through NDA preparation and post-acquisition integration after MyoKardia was acquired by Bristol Myers Squibb. - Barskaya founded Votum Consulting LLC after building a long-term network and gaining experience across large organizations and emerging biotech companies. - Votum Consulting helps clients design, build and optimize regulatory operations functions. - Her consulting work is aimed at improving quality, compliance and regulatory readiness while helping companies scale. - Barskaya also focuses on mentoring regulatory operations professionals and sharing knowledge across the life sciences community. - Her personal leadership approach emphasizes curiosity, initiative, collaboration, trust and reputation. - She says she built confidence over time by taking on public speaking, leadership visibility and cross-functional communication challenges. - Barskaya encourages women entering pharma and biotech to seek learning opportunities, step outside comfort zones and keep moving even when they do not feel fully prepared. - She identifies AI as one of the biggest challenges and opportunities in regulatory operations. - She says many organizations are still working out how to integrate AI responsibly while preserving compliance and quality standards. - She also points to pressure from accelerated development timelines and a growing pipeline of innovative therapies. - Her profile says digital transformation can streamline submissions, improve data management and speed decision-making. Between the lines: - Barskaya’s career path mirrors a broader industry need for operators who can translate regulatory complexity into repeatable systems. - The emphasis on AI suggests regulatory teams will need to modernize without weakening oversight, which could favor leaders with both technical and operational depth. - The profile also frames consulting as a natural extension of in-house regulatory leadership for companies that are scaling quickly. What’s next: - Barskaya is likely to keep advising life sciences clients on regulatory operations design, systems and submissions as the industry adapts to AI and tighter development timelines. - Her work will continue to focus on helping organizations balance innovation with compliance while improving operational efficiency. - Through Votum Consulting, she expects to support companies that need stronger regulatory infrastructure to advance therapies faster.