Ilona Barskaya
Ilona Barskaya is the Managing Partner of Votum Consulting LLC, a regulatory operations consulting firm supporting pharmaceutical and biotechnology companies in achieving operational excellence. With nearly two decades of experience in the life sciences industry, she has built a reputation as a strategic leader, trusted advisor, and expert in regulatory operations, systems, and submissions.
Ilona began her career at Genentech/Roche, where she entered the industry at an entry-level role and steadily advanced through the organization into senior leadership. Over more than a decade, she led global regulatory operations teams, managed complex submission portfolios, and played a key role in shaping long-term operational strategies, including workforce planning, outsourcing models, and large-scale process improvements.
She later joined MyoKardia, a growing biotech company, where she was brought in to establish and lead the Regulatory Operations function from the ground up. In this role, she defined the strategic vision for regulatory infrastructure, implemented enterprise systems including Veeva RIM, and guided the organization through critical milestones, including NDA preparation and integration following the company’s acquisition by Bristol Myers Squibb.
Building on her deep expertise and strong industry relationships, Ilona founded Votum Consulting, where she now partners with small to mid-sized pharma and biotech companies to design and optimize regulatory operations. Her work spans regulatory strategy, submission execution, system implementation, and process transformation—helping organizations scale effectively while maintaining compliance and quality.
Known for her collaborative leadership style and ability to translate complex challenges into practical solutions, Ilona is also passionate about mentoring professionals and contributing to the broader regulatory community. Her career reflects a consistent theme of growth, innovation, and impact—both within organizations and across the industry.
• San Francisco State University – BS, Business Administration & Management
• Stanford Continuing Studies – Business Administration and Management, General; Design Implementation: Getting to Market; Accelerate Your Startup Idea
• Preferred Vendor Recognition from System Provider
• Influential Women 2026
• Healthcare Businesswomen's Association (HBA)
• Regulatory Affairs Professionals Society (RAPS)
• The Alliance for Science (DA4S)
• The Drug Information Association (DIA)
• Governing Board Member, Project Giving Kids, Inc.
• Mentor at EVERWISE
• Parent Guild Member at Holy Name School
What do you attribute your success to?
I attribute my success to a combination of curiosity, continuous learning, and a willingness to step outside my comfort zone. When I began my career at Genentech, I entered the industry with very little background, so I made a conscious decision to ask questions, seek out knowledge, and fully immerse myself in every opportunity to learn. I joined professional groups, participated in industry associations, and treated every experience as a chance to grow.
I’ve also been fortunate to have incredible mentors and leaders throughout my career who invested in my development, challenged me to think bigger, and encouraged me to step outside my comfort zone. Their guidance not only accelerated my learning but also helped me see potential in myself that I might not have recognized on my own.
Equally important was pushing myself beyond what felt comfortable. As someone naturally introverted, developing confidence—particularly in areas like public speaking and leadership—was not immediate, but it became essential to my growth. Over time, I learned that confidence is built through action, preparation, and a willingness to take on challenges before you feel fully ready.
I also believe that success comes from building strong relationships and earning trust. Throughout my career, I focused on collaboration, delivering quality work, and being someone others could rely on. That foundation ultimately opened doors—whether it was stepping into leadership roles, being asked to build a function from the ground up, or launching my own consulting business.
At its core, my journey has been driven by a mindset of growth, resilience, and staying open to what’s next.
What’s the best career advice you’ve ever received?
The best career advice I’ve received hasn’t come from a single moment, but from the collective wisdom of the colleagues, mentors, and industry professionals I’ve had the privilege of working with throughout my career. Their guidance shaped not only my technical understanding of regulatory operations, but also how I approach leadership, problem-solving, and growth.
One theme that has consistently stayed with me is the importance of staying curious and never assuming you have all the answers. Early on, I was encouraged to ask questions, seek different perspectives, and truly understand the “why” behind processes—not just execute them. That mindset has been foundational in helping me navigate complex challenges and evolve alongside a constantly changing industry.
I was also advised to be proactive in creating opportunities rather than waiting for them. Whether it was raising my hand for new projects, stepping into unfamiliar roles, or building relationships across functions, that advice pushed me to grow faster and more intentionally.
Perhaps most importantly, I learned the value of investing in relationships and reputation. The trust and credibility you build over time become your strongest assets. That principle ultimately played a significant role in my transition into consulting and the ability to build and grow my own business.
Together, these lessons have shaped how I lead today—grounded in curiosity, initiative, and a strong commitment to collaboration and continuous learning.
What advice would you give to young women entering your industry?
I would encourage young women entering the pharma/biotech industry to stay curious, ask questions, and take every opportunity to learn. When I started at Genentech, I didn’t even know this industry existed, and I was early in my career—but I made a point to lean in, get involved, and absorb as much as I could. I joined professional groups, participated in associations, and said yes to opportunities, even when I wasn’t sure I was fully ready.
It’s also important to step outside your comfort zone. As someone who is naturally introverted, I had to intentionally push myself into situations that didn’t come easily—whether it was public speaking, leading meetings, or taking on visible roles. Growth doesn’t happen in comfort, and those moments are often where the biggest development occurs.
Confidence is another critical piece. Many women, myself included, experience moments of self-doubt or feel like they don’t quite belong, even when they are performing well. It’s important to recognize that those feelings are common and not a reflection of your abilities. Building confidence takes time, but trusting yourself, owning your accomplishments, and continuing to show up will make a significant difference.
Above all, be proactive in shaping your own path. This industry offers so many opportunities, and your willingness to explore, take risks, and believe in your potential will ultimately define your journey.
What are the biggest challenges or opportunities in your field right now?
One of the biggest challenges in the pharma/biotech industry right now is navigating rapid change—particularly with the emergence of AI. While there is tremendous potential, many organizations are still figuring out how to effectively and responsibly integrate these technologies into regulatory operations. At the same time, the regulatory landscape itself continues to evolve, requiring companies to stay agile and continuously adapt to new requirements and expectations.
The industry is also becoming increasingly competitive, with a surge of innovation and novel therapies entering development. There is significant pressure to bring these therapies to patients faster, which places a spotlight on operational efficiency, quality, and strategic execution within regulatory functions.
At the same time, these challenges present meaningful opportunities. AI, in particular, has the potential to transform how we approach regulatory processes—from streamlining submissions to improving data management and decision-making. For companies that embrace innovation thoughtfully, there is a real opportunity to enhance efficiency, reduce timelines, and ultimately accelerate patient access to life-changing therapies.
It’s an incredibly exciting time to be in this field, as we explore how to balance innovation with compliance and reimagine what effective regulatory operations can look like in the future.
What values are most important to you in your work and personal life?
The values that matter most to me—both professionally and personally—center around making a meaningful impact, continuous learning, and connection. In my work, I’m deeply driven by the desire to truly help the companies we partner with. My business partner and I are incredibly passionate about what we do, and we approach our work with a strong sense of responsibility and advocacy for our clients. We’ve seen firsthand the gaps that can exist in the support companies receive, and it motivates us to deliver a higher level of quality, fairness, and partnership—acting as a true extension of their teams and helping them operate more efficiently to ultimately bring therapies to patients faster.
I also place a high value on continuous learning. I’m naturally curious and always looking to grow—whether through reading, listening to podcasts, or gaining new perspectives from others. That mindset has been a constant throughout my career and continues to shape how I evolve both personally and professionally.
Equally important is family and personal connection. As a mother with a child in college and a teenage daughter, I’m very intentional about spending quality time with my family. After years of focusing heavily on building my career and business, I’ve come to deeply value balance—making time to relax, connect with friends, and enjoy life’s everyday moments.
At the core, it’s about purpose, growth, and relationships—bringing that same sense of care and intention to both my work and my life.