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Regulatory Careers at Parexel

Helping bring therapies to patients through regulatory expertise

At Parexel, Regulatory professionals play a critical role in helping innovative therapies move from development to approval and beyond. Working across Regulatory Science, Regulatory Affairs & Operations, Compliance, CMC, Labeling and Regulatory Systems, our teams partner with clients around the world to navigate complex regulatory pathways and accelerate patient access to life-changing treatments.

As one of the world's largest and most experienced regulatory organizations, Parexel combines global expertise, scientific knowledge, and regulatory insight to support products throughout the entire development lifecycle. From early development planning and health authority interactions to submissions, approvals, and lifecycle management, our teams help clients make informed decisions that ultimately benefit patients.

Whether you're interested in shaping development programs, guiding global submissions, supporting compliance initiatives, or helping organizations prepare for evolving regulatory requirements, you'll find opportunities to make a meaningful impact while growing your career alongside industry-leading experts.

Join our Regulatory team and help advance therapies for patients around the world, With Heart®.

Our Regulatory Impact

  • 30,000+ regulatory submissions published annually

  • 25,000+ regulatory maintenance activities performed annually (variations, renewals, etc.)

  • 2,500+ global regulatory resources across regulatory strategy, CMC, labeling and more

  • 30+regulatory partnerships with both large and mid-sized Pharma

Explore Our Regulatory Specialties

From regulatory submissions and compliance to scientific strategy and health authority engagement, our teams help clients navigate regulatory challenges throughout the product lifecycle. Learn more about our Regulatory Affairs & Operations, Compliance and Regulatory Science teams below.

Regulatory Affairs & Operations

Compliance

Regulatory Science

Regulatory Affairs & Operations

Regulatory Affairs & Operations professionals support regulatory submissions, publishing, approvals and lifecycle management activities across global markets. The team works closely with health authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), National Medical Products Administration (NMPA) and other regulatory agencies around the world.

The work spans a broad range of therapeutic areas and product types, including rare diseases, orphan drugs, over-the-counter products and cell and gene therapies. Through every stage of development and commercialization, the team helps clients navigate regulatory requirements and bring new therapies to patients.

Jessica Jung

Director, Regulatory Affairs


“At Parexel, prioritizing patients is not just a directive; it is a way of life for each employee. This shared dedication is evident in our daily practices, extending beyond words to influence our actions and decisions. We understand that the work we do has a profound impact on people's lives, and this understanding is reflected in our relentless pursuit of excellence.”

Read Jessica's Story

Irene, brown haired woman wearing a grey sweater, smiling while sitting on the bank for a river

Irene Spitaleri
Senior Regulatory Affairs Consultant


“Working 'With Heart' means that I put people at the center of my daily life. I ensure to never forget that anyone from patients, friends and family to colleagues could be impacted by my job.”

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Yuri, brown haired male, standing on-top of a mountain

Yuri Ceragioli
Regulatory Affairs Consultant



“Parexel stands out in its genuine commitment to employee well-being and growth. The company's approach to work-life balance is refreshing, offering flexibility and smart-working options that truly support personal life.”

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Vidushi with long brown hair wearing a light brown clothing

Vidushi Dobhal
Regulatory Affairs Consultant


“Working at Parexel is like being part of a community where we're all driven by the same goal: to enhance healthcare through science while truly living patient centricity. It's demanding, exciting, and incredibly fulfilling.”

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Regulatory Affairs Career Paths

Regulatory Affairs professionals can pursue a variety of career paths while building expertise across submissions, publishing, regulatory operations, and lifecycle management. From entry-level roles to senior leadership positions, our Regulatory Affairs team offers opportunities to grow expertise, take on new challenges, and build experience across therapeutic areas, product types and global markets. 


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Compliance

Parexel's Compliance team combines deep regulatory knowledge and industry expertise to help organizations strengthen quality systems, manage risk and maintain inspection readiness.

The team supports clients across GxP compliance, auditing services, quality management systems, data integrity, remediation programs, regulatory training and inspections support. By combining regulatory expertise with practical industry experience, Compliance professionals help organizations navigate complex challenges while maintaining high standards of quality, compliance and patient safety.

Kevin Nolan

Principal Consultant


“The unique blend found in the Parexel Strategic Compliance Consulting team of extensive regulatory knowledge and industry experience by former FDA investigators and industry experts truly sets Parexel apart. Our team brings a deep understanding of the Regulatory landscape, coupled with a practical perspective on the challenges faced by companies in the life sciences industry. Parexel’s ability to navigate complex regulatory requirements while considering the operational and business aspects of clients enables Parexel to offer strategic and efficient solutions.” 

Kevin Nolan headshot

Regulatory Science

By combining scientific expertise, regulatory intelligence and knowledge of global requirements, the team helps clients develop efficient development programs and navigate increasingly complex regulatory environments. Their work spans a wide range of therapeutic areas and emerging technologies, helping clients move innovative therapies forward while keeping patient needs at the center of every decision.


Mwango Kashoki
Head of Regulatory Science

“There's a lot of support for individuals to engage in professional development, such as attending or speaking at professional meetings, authoring articles, or taking a training course. Professional development helps us keep abreast of advances in science, R&D and regulations, which helps us be effective consultants to our customers.” 

Sheryl Perry
Principal Regulatory Affairs Consultant

“What I really enjoy and excites me about my role is feeling that I'm making a difference, both to the clients and ultimately to patients.”

Steve Winitsky
SVP, Regulatory Science - Clinical, CGT

“I always think of my role as ambassadors for Parexel, since we’re front and center when it comes to helping our clients navigate the regulatory complexities of the development program and interacting with Health Authorities as the product moves from first-in-human trials toward licensure and post-marketing.”

Development Programs and Insights

Regulatory professionals at Parexel have access to a variety of development opportunities designed to support long-term career growth and continued learning. 

Lunch and Learn

Our Lunch and Learn sessions cover timely topics about our industry, innovations, and best practices. Delivered by Parexel experts, these open offerings provide valuable insights and real-world examples. Expand your knowledge and network while staying updated on the latest developments in clinical research.

Therapeutic Area Knowledge

Parexel helps you stay current in key Therapeutic Areas. We offer best-in-class learning modules, webinars, and expert connections. Our Learning & Development team provides a certification program to formally build your expertise. These resources ensure you're well-informed and prepared to excel in your chosen areas.

Management Development

Our "Managers Matter" initiative provides comprehensive support for leaders. New managers receive targeted learning and a quick start guide. Monthly sessions offer relevant information and practical tips. Regular self-paced and instructor-led offerings help managers enhance their skills, ensuring they're well-equipped to lead effectively.


Innovation and expertise are central to who we are.

Our Regulatory professionals contribute thought leadership, scientific publications and industry insights that help shape conversations across the regulatory landscape. Through publications, conference participation and industry engagement, our experts continue advancing the future of regulatory consulting.

Featured Jobs

Explore current opportunities across Regulatory Affairs, Regulatory Science, Compliance, CMC, Labeling, Regulatory Systems and more. Join a team helping clients navigate complex regulatory challenges and bring therapies to patients around the world.


Featured Jobs

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