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Ensuring Regulatory Excellence

With a team of over 1,300 experienced professionals across 110 countries, Parexel's Regulatory department is comprised of various backgrounds, including industry veterans, academic scholars, and former agency regulators. This highly integrated and synergistic group excels in coordinating, managing, and leading our clients through regulatory landscapes worldwide.

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.

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"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

  • 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

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 & Operations

Compliance

Regulatory Strategy

Regulatory Affairs & Operations

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.

 

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."

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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. Uncover how Jo Wang has leveraged her FDA expertise to rise to VP Technical at Parexel, where she exemplifies our "With Heart" value daily, helping to accelerate medicine delivery.


Regulatory Strategy

Parexel's Regulatory Strategy Team combines a wealth of regulatory knowledge and expertise to support companies globally with their product development strategy, interactions with regulatory authorities, and regulatory submissions. Our goal is to establish innovative and efficient development programs that ultimately meet patients' needs. Leveraging our regulatory intelligence and aligning with current best practices, including Good Clinical Practice (GCP), we develop tailored and robust strategies. By fostering collaboration across teams and leveraging diverse skills, we provide clients with strategic guidance and support, enabling them to make well-informed decisions at every stage of the drug development journey.
  
Hear from some of our 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.

 

Mwango Kashoki
Senior Vice President & Global Head of Regulatory Strategy

"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."

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Sheryl Perry
Principal Regulatory Affairs Consultant, Regulatory Strategy

“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.”

 

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Steve Winitsky
Vice President Technical, Regulatory Strategy

"I always think of the VP Tech’s 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."

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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.


Professional and Personal Development Spotlight

Navigating your career

  • New or recently promoted employees seeking clarity on their role and contribution.
  • Employees with a tenure of 1-2 years wanting to increase their engagement, satisfaction levels and clarity around their aspirations.
  • Employees with a tenure of 3-6 years wanting to increase their organizational acumen and maintain and build a professional network. 

Advancing women's leadership

  • We offer several programs to inspire and empower women who show promise as future leaders and are interested in taking their careers to the next level.
 
    • Manager level +:  WISDOM Circles
    • Director level +: Women in Leadership
    • CVP level +: Women unlimited LEAD

Diversity, Equity and Inclusion 

  • We offer DE&I programs and external partnerships to expand inclusion and to provide ongoing career development.
 
    • All employees mandatory: Diversity & Inclusion is Parexel
    • All employees optional: Unconscious Bias, Inclusive Culture, LGBTQ+ Safe Zone
    • Director level +: Inclusive Leadership

Managing With Heart™

  • Teaches new managers the essential skills to drive higher performance, lower turnover, and increased accountability - all tenets of our We Care Strategy.

On-demand learning platform

  • It's crucial that you find the best career development options for your needs. On-demand learning offers a wide range of training at your convenience.

Lunch & Learn sessions 

  • The topics span career and personal development, DEI, intercultural working, resilience, insights into other roles or departments, job-related updates on guidelines, etc.

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