Ensuring Regulatory Excellence

"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

At Parexel, our Regulatory Affairs and Operations team ensures that regulatory submissions and activities adhere to the guidelines and regulations set by global health authorities, including the US Food and Drug Administration (US-FDA), European Medicines Agency (EMA), and National Medicinal Products Administration (NMPA). By developing unique regulatory strategies, securing submission approvals, and maintaining compliance for trials and products, our team plays a pivotal role in regulatory success. Joining our regulatory team means you'll gain experience across a variety of projects and therapeutic areas, including Orphan Drug, Rare Disease, OTC Drug, Cell and Gene Therapies (C&GT), and more.

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

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