Meet Oscar, Regulatory Affairs Consultant

What does a day in the life of your role look like?

 Imagine being at the forefront of groundbreaking medical advancements. As a Regulatory Affairs Consultant, my days are a thrilling blend of strategy and problem-solving. I craft regulatory strategies for clinical trials, ensuring they dance in perfect harmony with both local regulations and client goals. Picture yourself leading local regulatory teams, guiding them through the intricate maze of protocol approvals across different countries. You'll be the maestro of regulatory submissions, ensuring every 'i' is dotted and 't' is crossed throughout the trial's journey. Collaboration is key - you'll be the bridge between Clinical Operations, Study Start-Up, and other crucial functions, keeping everyone in sync. As the go-to regulatory expert for clients, you'll become a master of understanding needs, tackling queries, and delivering timely updates. Each day brings new regulatory puzzles to solve, challenging you to find innovative solutions that keep trials on track while staying within the lines of compliance.

What part of your job ignites your passion for clinical research?

What really drives my passion is navigating the ever-evolving regulatory landscape. The constant learning and problem-solving keep the role engaging and challenging. I particularly enjoy the collaborative aspect of our work - engaging with cross-functional and international teams provides diverse perspectives and enriches our approach. Ultimately, knowing that our efforts contribute to bringing potentially life-changing therapies to patients is what makes this role truly fulfilling.

What skills are needed to be successful within your team?

Success in our team requires a combination of adaptability, attention to detail, and strong organizational and communication skills. The ability to navigate complex regulatory landscapes effectively is crucial. Equally important is staying current with evolving regulations and guidelines - this continuous learning is essential in our fast-paced field.

If you could give prospective team members one key insight about this position, what would it be?

While challenging, being a Regulatory Affairs Consultant is incredibly rewarding. It offers the opportunity to directly contribute to bringing new treatments to patients. Candidates should be prepared for a dynamic, fast-paced environment where their expertise can significantly impact the drug development process. The role demands resilience and adaptability, but the satisfaction of knowing your work makes a real difference is unparalleled.

Can you describe a particularly fulfilling project you've been involved with and explain what made it so rewarding?

One of the most rewarding projects I've worked on at Parexel involved an ultra-rare disease trial for pediatric patients. This project was particularly meaningful due to its potential impact on a small but significantly affected patient population. Navigating the complex regulatory landscape for pediatric and rare disease trials presented unique challenges. Successfully overcoming these obstacles highlighted how our work at Parexel directly contributes to advancing treatments for patients with limited options.

Why did you choose the Clinical Research industry?

My path to the Clinical Research industry began with an early interest in life sciences, which led me to pursue a degree in Biotechnology Engineering. During my studies, I became increasingly interested in applying scientific innovation to improve people's lives. The Clinical Research field offered a unique opportunity to bridge cutting-edge science with practical patient care. I was drawn to the idea of contributing to the development of therapies that could enhance the quality of life for patients and their families. The dynamic nature of clinical research, with its constant advancements and challenges, continues to keep me engaged and motivated in this career.

Can you share a unique aspect of working at Parexel that sets it apart from your previous professional experiences?

At Parexel, I've encountered an unparalleled commitment to quality and inclusivity. Our Quality Management System isn't just a set of guidelines—it's the backbone of our daily operations and decision-making. [Updated] Parexel's dedication to inclusion goes beyond mere policy; it's a lived experience that shapes our work environment. [Updated] What truly sets Parexel apart is its forward-thinking approach to technology. The company's strategic adoption of AI and other cutting-edge technologies in clinical trial processes puts us at the forefront of industry innovation.

How do you work With Heart™ and what does it mean to you?

Working With Heart™ at Parexel means approaching every task with the awareness that our work directly impacts patients' lives. In my role as a Regulatory Affairs Consultant, this principle guides me to keep patients at the forefront of my mind, ensure the highest quality in regulatory submissions, and collaborate empathetically with colleagues and clients.

How does Parexel foster a culture of flexibility and work-life balance?

As a remote worker, I benefit from excellent technological infrastructure and flexible work policies. My line manager actively listens to my needs, fostering trust. Parexel's commitment to flexibility allows me to balance work responsibilities with personal commitments effectively.

How do you feel empowered throughout your job?

My expertise is valued, and I'm encouraged to make decisions within my area of responsibility. This trust and autonomy empower me to take ownership of my work and contribute meaningfully to our projects.

What specific practices or mindsets do you and your colleagues adopt to ensure the highest standards of quality in your work?

Quality isn't just a goal at Parexel—it's ingrained in our DNA, especially in regulatory affairs. We approach each submission with the mindset that it could be the one that brings a life-changing treatment to patients.  I consistently strive to deliver high-quality work on the first attempt, recognizing the critical nature of our submissions in the drug development process. Our team fosters a culture where quality is everyone's responsibility, encouraging open discussions about potential issues and sharing best practices and lessons learned.

In what specific ways does your position align with and reinforce Parexel's core values and behaviors?

As a Regulatory Affairs Consultant, I don't just follow Parexel's core values—I embody them in my daily work. I 'Commit to excellence' by striving for high-quality submissions on the first attempt, staying updated on regulatory requirements, and continuously improving our processes. I 'Win as one team' through active collaboration with cross-functional teams, sharing knowledge, and fostering open communication. I 'Deliver "With Heart" and determination' by keeping patients at the forefront of every decision, especially when working on critical projects like the ultra-rare pediatric disease protocol. This patient-centric approach drives my determination to overcome regulatory challenges. Finally, I 'Own the outcome' by taking full responsibility for my regulatory submissions, proactively managing timelines, and ensuring compliance.

What personal habits or mindsets have you found particularly valuable?

In my personal and professional life, I've developed key habits and beliefs that drive success. Continuous learning is paramount – I actively seek new knowledge, which fuels my growth in this dynamic industry. Staying informed about global events is crucial in our interconnected field. I've learned to view mistakes as valuable learning opportunities, always analyzing how to improve future outcomes. Gratitude is another practice I've found essential for maintaining a positive perspective. Autonomy and accountability are cornerstones of my approach. By owning the outcomes of my work, I foster personal responsibility and drive better results. Sharing knowledge and lessons learned is also crucial – it contributes to our collective growth and improves our overall performance. I believe strongly in helping others whenever possible. This not only supports team success but also creates a positive work environment. Lastly, maintaining humility keeps me open to feedback and new ideas, which is vital in the ever-evolving landscape of regulatory affairs.

What do you enjoy outside of work?

Outside of work, I'm passionate about swimming and have even participated in open water events. This hobby helps me stay active and balanced. I also find joy in caring for my animal companions: two goldfish, three budgerigars, and one chihuahua dog. Their presence in my life provides a welcome contrast to my professional responsibilities. Above all, family time is incredibly important to me. I deeply value the moments I spend with my loved ones, which help me recharge and maintain perspective in my life and work.