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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.

Intro/Headline Here

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Intro/Headline Here

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

Intro/Headline Here

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Vidushi with long brown hair wearing a light brown clothing

Intro/Headline Here

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If applicable, a bulleted list could go here:

  1. Typi non habent claritatem insitam; est usus legentis
  2. Bin iis qui facit eorum claritatem. Investigationes demonstraverunt. Eodem modo typi, qui nunc nobis videntur.
  3. Electores legere me lius quod ii legunt saepius
  • Claritas est etiam processus dynamicus, qui sequitur mutationem consuetudium lectorum. Mirum est notare quam littera gothica.
  • Quam nunc putamus parum claram, anteposuerit litterarum
  • Quam nunc putamus parum claram, anteposuerit litterarum
Image of the career path for a Regulatory Affairs professional

Compliance

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Learn More

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 the Regulatory Science team 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.”

TRABAJO QUE PRIORIZA A LOS PACIENTES

Diseñamos un aprendizaje dirigido para aumentar su éxito en el trabajo. Nuestros programas y recursos personalizados abordan específicamente nuestra industria y las necesidades únicas de su desarrollo.

Revise nuestras áreas de desarrollo más relevantes y populares:

Explorar su carrera profesional

  • Empleados nuevos o recientemente ascendidos que buscan claridad sobre su función y contribución.
  • Empleados con una antigüedad de 1 a 2 años que desean aumentar su compromiso, niveles de satisfacción y claridad en torno a sus aspiraciones.
  • Empleados con una antigüedad de 3 a 6 años que desean aumentar su visión organizacional y mantener y construir una red profesional.k. 

Promoción del liderazgo de las mujeres

  • Ofrecemos varios programas para inspirar y empoderar a las mujeres que se muestran prometedoras como futuras líderes y que están interesadas en llevar su carrera profesional al siguiente nivel.
 
    • Nivel de gerente +: círculos WISDOM
    • Nivel de director +: mujeres en el liderazgo
    • Nivel de CVP +: programa Women unlimited LEAD

Diversidad, equidad e inclusión 

  • Ofrecemos programas de DE&I y asociaciones externas para ampliar la inclusión y brindar un desarrollo profesional continuo.
 
    • Obligatorio para todos los empleados: Parexel es Diversidad e Inclusión
    • Opcionales para todos los empleados: Sesgo inconsciente, Cultura inclusiva, Zona segura de LGBTQ+
    • Nivel de director +: Liderazgo inclusivo

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Typi non habent claritatem insitam; sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.

If applicable, a bulleted list could go here:

  1. Typi non habent claritatem insitam; est usus legentis
  2. Bin iis qui facit eorum claritatem. Investigationes demonstraverunt. Eodem modo typi, qui nunc nobis videntur.
  3. Electores legere me lius quod ii legunt saepius
  • Claritas est etiam processus dynamicus, qui sequitur mutationem consuetudium lectorum. Mirum est notare quam littera gothica.
  • Quam nunc putamus parum claram, anteposuerit litterarum
  • Quam nunc putamus parum claram, anteposuerit litterarum

Professional and Personal development Spotlight

This is where a subhead woud go - qui facit eorum claritatem.

Typi non habent claritatem insitam; sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.

If applicable, a bulleted list could go here:

  1. Typi non habent claritatem insitam; est usus legentis
  2. Bin iis qui facit eorum claritatem. Investigationes demonstraverunt. Eodem modo typi, qui nunc nobis videntur.
  3. Electores legere me lius quod ii legunt saepius
  • Claritas est etiam processus dynamicus, qui sequitur mutationem consuetudium lectorum. Mirum est notare quam littera gothica.
  • Quam nunc putamus parum claram, anteposuerit litterarum
  • Quam nunc putamus parum claram, anteposuerit litterarum

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