Meet Simona, Vice President Technical,
Regulatory Strategy

Tell us about yourself and your journey to Parexel.

Although I joined Parexel in 2021, it still feels like I'm on the early chapters of my journey here. With my background as a Medical Doctor, I've found my niche as a Vice President Technical in Regulatory Strategy, where I serve as a subject matter expert for clinical pharmacology and regulatory affairs.

Before Parexel, I completed my clinical pharmacology residency in Lithuania, where I'm still based, and worked as a clinical assessor for our State Medicines Control Agency. There, I was honored to be appointed as an Alternate CHMP member, which exposed me to a wide spectrum of centralized procedures—from marketing authorization applications to scientific advice procedures and beyond.

What attracted you to Parexel's Regulatory team?

While I was ready for a career change for personal reasons, Parexel's recruitment process truly set it apart from other opportunities. I was impressed that they arranged meetings with five team members - people I still work closely with today. This showed me they cared as much about cultural fit as technical expertise, and it gave me valuable insight into the team I'd potentially join.

The conversations were substantive, focusing on my potential role and contributions rather than generic interview questions. I was also drawn to Parexel's scale and diversity of business units, which promised numerous growth paths. When I considered all these factors together, the decision became clear—there simply wasn't a better place for me to continue my professional journey.

What does your role involve, and what does a day in your life at Parexel look like?

I'm part of a diverse team that brings together expertise from quality (CMC), non-clinical, and clinical backgrounds to guide clients through their entire product development journey. We're there at critical milestones, whether launching development programs or navigating those high-stakes moments when clients present to regulatory agencies for approvals. We're also there for everything in between, helping with regulatory interactions ranging from special designations to pediatric development plans.

My days begin with prioritizing emails and project tasks, addressing urgent client questions first. One of my favorite aspects is consulting with clients on clinical trial conduct, where I can directly support our operational colleagues. In essence, my work is a blend of deep reading, strategic writing, and critical thinking—three elements that keep every day intellectually stimulating!

What challenges and excites you most about your work?

My role presents both logistical and professional challenges that keep me engaged. Working fully remotely offers tremendous flexibility, but it requires intentional effort to maintain strong connections when interactions happen primarily through screens and calls.

The professional transition from government, public healthcare, and academia to industry was significant, involving new responsibilities, diverse project types, and engagement with different regulatory bodies. But this transition is precisely why I chose Parexel. I was seeking professional challenges that would stretch my capabilities and accelerate my growth. The learning curve has been steep at times, but that's exactly what makes the work so rewarding.

Can you share a project that's been particularly meaningful to you?

We're currently advancing a breakthrough treatment for severe infections toward approval in both the US and Europe. What makes this project especially meaningful is that, as a former clinician, I can envision exactly how this drug will transform care for critically ill patients in ICUs.

Contributing to something that my former clinical colleagues will soon be able to prescribe to their most vulnerable patients gives profound purpose to my regulatory work. Seeing the direct line between our regulatory strategy and potentially saved lives reminds me daily of why precision and excellence matter so much in what we do.

How has Parexel fueled your professional growth?

The greatest catalyst for my development has been collaborating with colleagues who bring diverse perspectives from different regulatory agencies and industry backgrounds. This exposure has transformed how I approach problems and evaluate projects. Working across various regulatory authorities and with a wide spectrum of client products has expanded my expertise in ways that wouldn't have been possible elsewhere.

Parexel has invested in my growth through conference opportunities and comprehensive training through our learning management system. This combination of peer learning, hands-on experience with novel challenges, and formal development resources has accelerated my expertise tremendously during my time here.

What principles guide your approach to life and work?

I believe in the power of initiative - sometimes it's better to ask for forgiveness than permission, especially when you see an opportunity to make a meaningful difference. This approach has led to some of my most valuable contributions, though it requires good judgment about when to apply it.

Equally important is my commitment to treating others how they want to be treated, not how I think they should be treated. Recognizing and respecting different perspectives and boundaries creates stronger relationships and more effective collaboration—principles that serve me well both professionally and personally.

How does Parexel support your work-life balance?

Parexel's approach to flexibility has been transformative for my work-life integration. As a fully remote employee, I have the autonomy to structure my workday in ways that optimize my productivity while accommodating personal needs.

Our regulatory strategy team embodies true collaboration - when project loads intensify, there's always someone ready to share responsibilities. My line manager and project leaders demonstrate genuine respect for time zone differences and personal boundaries. This supportive environment allows me to deliver my best work without sacrificing personal wellbeing - a balance that makes long-term success possible.

What passions fill your time outside of work?

Lithuania's spectacular summers captivate me with their uniquely long evenings and that magical quality of light that lingers until the late hours. During these months, you'll find me tending to my garden and greenhouse, a passion that connects me to nature and provides a perfect counterbalance to my analytical work life.

When winter arrives and gardening pauses, I recharge through reading, fitness, cooking, and immersing myself in strategic games. My current favorite is Arkham Horror, which is a card game with such intricate complexity that hours fly by as I navigate its challenges. I'm still mastering its nuances, but the mental engagement it offers is completely absorbing!

Has there been any piece of advice or literature that has left a lasting impression on you?

Harper Lee's 'To Kill a Mockingbird' remains a touchstone for me - a book I return to repeatedly because it reveals new layers of meaning with each reading. Recently, I've discovered Ben Macintyre's spy novels, which offer fascinating insights into human nature and decision-making under pressure.

I'm an avid reader across genres, but what I love most about reading is that complete immersion experience - when you find a book so compelling that everything else fades away until you've reached the final page.