About this role
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a dedicated Regulatory Affairs Professional to join our growing team. This role offers an opportunity to work with global and local regulatory teams, supporting product lifecycle management and ensuring compliance with health authority requirements. The role can be home or office based.
Role Responsibilities:
Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
Coordinate health authority interactions and responses to questions
Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
Maintain up-to-date local national systems according to local legislation
Manage impact assessments for technical changes affecting marketing authorizations
Stay current on regulatory requirements and guidelines to ensure compliance
Support health authority inspections as needed
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives
Skills and Experience required for the role:
University Degree in a Scientific or Technical Discipline
A few years of experience in an industry-related environment
Experience in regulatory authority-facing roles
Regulatory Operations (Submission management) experience
Experience using Veeva Vault RIMS - strong plus
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken
Other facts
About Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 24,000+ professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award.
Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
• Spamming.
We reserve the right to remove comments that do not adhere to our guidelines and report users who violate the rules of our page.
What you'll do
- The Regulatory Affairs Generalist will support global and local regulatory teams, manage post-authorization lifecycle maintenance procedures, and coordinate health authority interactions. The role also involves preparing documentation to meet submission requirements and ensuring compliance with regulatory guidelines.
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