Carving a new path to deliver for patients. And I do it
Ensuring Regulatory Excellence
As the largest and most experienced regulatory consultancy group globally, Parexel offers unparalleled expertise and a vast global reach. Our comprehensive services span from product profiling and regulatory strategy to compliance, publishing and submission, commercialization planning, and ongoing lifecycle management support. Our teams are dedicated to maximizing success in drug development, ensuring new treatments reach patients faster.
Our progressive integration of clinical and regulatory consulting expertise enables our teams to engage in a variety of innovative studies, continually expanding their knowledge and driving forward the frontiers of medical science. Join us at Parexel, where collaboration, passion, and excellence converge to transform patient care.
"Parexel has enabled me to gain experience across a variety of diseases and drug products while strengthening and broadening my knowledge of regulatory affairs. The variety of my work, along with support from my colleagues and manager, allows me to continue learning and supports my professional growth."
- Liam Fitzgerald, Senior Regulatory Affairs Associate
Our Regulatory Impact
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30,000+ regulatory submissions published annually
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25,000+ regulatory maintenance activities performed annually (variations, renewals, etc.)
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2,500+ global regulatory resources across regulatory strategy, CMC, labeling and more
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30+regulatory partnerships with both large and mid-sized Pharma
Our Approach to Regulatory Effectiveness
We achieve regulatory excellence through three focused teams: Regulatory Affairs & Operations, Compliance and Regulatory Strategy. Learn about our teams and how they work every day With Heart™.
Regulatory Affairs & Opperations
At Parexel, our Regulatory Affairs and Operations team is responsible for ensuring regulatory submissions and regulatory activities comply with guidelines and regulations set by global health authorities such as the US Food and Drug Administration (US-FDA), European Medicines Agency (EMA), and National Medicinal Products Administration (NMPA). Through developing unique regulatory strategies, gaining submission approval, maintaining trials and products in a state of compliance and more; our team plays a crucial role in ensuring regulatory activities are completed compliantly. Working on our regulatory team, you’ll gain experience with a variety of projects and therapeutic areas, including Orphan Drug, Rare Disease, OTC Drug, Cell and Gene Therapies, and much more.
Jessica Jung
Associate Project Director
"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."
Compliance
Parexel’s Strategic Compliance Team combines a wealth of regulatory compliance knowledge and expertise to support companies globally with building cultures of compliance, while mitigating risks, managing remediations, and restoring client reputations. Our goal is to tailor solutions that make sense for our clients and the patients they serve. By fostering collaboration and leveraging diverse skills, we provide clients with strategic compliance guidance, inspection readiness, inspections support, a wide range of GxP auditing services, data integrity, training, and building quality management systems. We help clients navigate complex regulatory landscapes while maintaining high standards of quality and compliance.
“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, Principal Consultant
Through leveraging our unique fusion of scientific, regulatory, and business proficiency the Compliance group applies unparalleled breadth and depth of expertise that offer services to create and maximize product value for clients throughout the product lifecycle. Learn from Jo Wang, VP Technical, about how her US-FDA background prepared her for her current role and how she continues to work "With Heart" to accelerate the delivery of medicine to patients.
Regulatory Strategy
Insights
Explore the fascinating world of clinical research as our Regulatory experts uncover the latest trends, industry updates, and valuable insights of the ever-evolving regulatory landscape.
- Regulatory acceptability of AI: Current perspectives
- Breakthrough Devices Program: Where’s the value?
- Advancing clinical development through innovative trial design
- English Requirement for FDA GMP Documents
- Optimizing the Route to Regulatory Approval for a Novel Vaccine
- Cell & Gene Therapies: A Regulatory Update
Professional and Personal Development Spotlight
Explore Parexel
2023 Scrip Awards"Best Contract Research Organization" – Full-service category
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2023 SCRS’s
Eagle Awardfor strong site relationships
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Recognized by Flexjobs for our remote-and hybrid-friendly culture
LinkedIn Top Companyfor Career Progression in Healthcare
CRO Leadership Award for 10 consecutive years
“Silver” rating by Ecovadis for business sustainability exceeding all industry benchmarks
Top 20% ranking on the Human Rights Campaign’s Corporate Equality Index 2022
Catalyst Award Winner for advancing women in the workplace
2023 Scrip Awards"Best Contract Research Organization" – Full-service category
2023 SCRS’s Eagle Awardfor strong site relationships
Recognized by Flexjobs for our remote-and hybrid-friendly culture
LinkedIn Top Companyfor Career Progression in Healthcare
CRO Leadership Award for 10 consecutive years
“Silver” rating by Ecovadis for business sustainability exceeding all industry benchmarks
Top 20% ranking on the Human Rights Campaign’s Corporate Equality Index 2022
Catalyst Award Winner for advancing women in the workplace
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