I’m working toward a better future for patients. And I do it
Ensuring Regulatory Excellence
Our Regulatory department is made up of over 1,000 experienced experts spanning across 110 countries; bringing diverse backgrounds ranging from industry, academia, to agency. The highly integrated and synergistic group assists with coordinating, managing, and successfully leading our clients’ with regulatory agencies around the world.
From product profile and regulatory strategy to compliance, publishing and submission, commercialization planning and ongoing lifecycle management support, our teams are maximizing success in drug development to bring new treatments to patients faster. The progressive way we integrate clinical and regulatory consulting expertise allows for our teams to work on a variety of innovative studies and expand their knowledge.
Explore all Regulatory opportunities
Regulatory Affairs and Operations
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.
Cara Gu
Senior Manager, Regulatory Affairs
"There's a lot of independence within the Regulatory department, but you also have a very reliable team that you can fall back on if you ever have questions or encounter a challenging situation from health authority.”
Liam Fitzgerald
Senior Regulatory Affairs Associate
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.
Compliance
As part of Parexel Consulting, our colleagues play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, our team works closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
“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.
Regulatory Strategy
Seeking a role where no two days are the same, and where you can apply your scientific and regulatory knowledge to help companies achieve their medical product development objectives? Our expert Regulatory Strategy team supports companies globally with their product development strategy, interactions with regulatory authorities, and regulatory submissions, with the overall goal to establish innovative and efficient development programs that ultimately meet patients’ needs.
Hear from some colleagues on our Strategy team on why they chose Parexel, what excites them about the work they do, and how having an adaptability mindset is one of the best assets to have when working within Regulatory.
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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