Poland · Remote OK
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 de…
Skills: Regulatory Compliance, Quality Assurance, GxP Regulations, Controlled Document Management, Inspection Readiness
Warsaw, Masovian Voivodeship, Poland · Remote OK
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 de…
Skills: eClinical Platform Implementation, Requirements Gathering, Clinical Trial Systems Configuration, Project Management, Client Management
Bloemfontein, Free State, South Africa · Remote OK
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 de…
Skills: eClinical Platform Implementation, Requirements Gathering, Clinical Trial Systems Configuration, Project Management, Client Management
Bucharest, Romania · Remote OK
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 de…
Skills: eClinical Platform Implementation, Clinical Trial Systems Configuration, Requirements Gathering, Project Management, Client Management
Italy · Remote OK
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 de…
Skills: Site Management, Site Monitoring, Clinical Trial Execution, ICH/GCP, FDA Regulations
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Project Management, Clinical Trial Leadership, Budget Management, Resource Management, Project Scheduling
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Program Management, Line Management, FSP Clinical Operations, Resource Forecasting, Client Relationship Management
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Project Management, Clinical Trial Leadership, Budget Management, Resource Management, Project Scheduling
Mumbai City, Maharashtra, India · On-site
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 de…
Skills: Clinical Operations, Project Management, Clinical Trial Management
Beijing, Beijing, China · On-site
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 de…
Skills: Medical Writing
Turkey · Remote OK
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 de…
Skills: Study Management, Risk Identification and Mitigation, Strategic Planning, Critical Path Analysis, Analytical Problem Solving
Newton, Massachusetts, United States · Remote OK
$178k–$196k/yr
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 de…
Skills: Build and Release Engineering, CI/CD Pipelines, Jenkins, Microsoft Azure, Java
Quebec, Quebec, Canada · Remote OK
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 de…
Skills: R Programming, SQL, Real-World Data Analysis, Epidemiology, Statistical Analysis
Beijing, Beijing, China · On-site
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 de…
Skills: Problem Solving, Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), MS Office, Interpersonal Communication
Bengaluru, Karnataka, India · Remote OK
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 de…
Skills: EMA Submissions, xEVMPD, Veeva Vault RIM, Lifecycle Management, EU Regulatory Processes
Beijing, Beijing, China · On-site
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 de…
Skills: Clinical Writing, Regulatory Documentation, Quality Control, Project Management, Medical Editing
Sydney, New South Wales, Australia · Remote OK
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 de…
Skills: Problem Solving, Presentation Skills, Client Relationship Management, Analytical Skills, Teamwork
Texas, United States · Remote OK
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 de…
Skills: Clinical Trial Monitoring, ICH/GCP, FDA Regulations, Oncology, Site Management
Bloemfontein, Free State, South Africa · Remote OK
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 de…
Skills: Clinical Trial Applications, Regulatory Submissions, Project Management, Process Optimization, Veeva Regulatory Vault
Spain · Remote OK
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 de…
Skills: Clinical Trial Support, Site Activation, Clinical Operations, ICH/GCP Compliance, Regulatory Submissions
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The role focuses on strengthening global regulatory compliance and quality operations across GxP environments. Key duties include managing controlled documents, overseeing training governance, and leading inspection readiness for health authorities.
Candidates need a Bachelor's degree in Life Sciences or a related field and over 8 years of experience in Regulatory Compliance or Quality Assurance. Proficiency in global GxP regulations and experience with eDMS platforms like Veeva Vault are required.
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 highly collaborative Regulatory Affairs Consultant – Compliance & Process to strengthen global regulatory compliance and quality operations across GxP environments. You will partner with Regulatory Affairs, Quality, CMC, Clinical Operations, and other cross-functional teams to enable compliant, efficient, and scalable business operations.
This is a client dedicated project and can be based remotely of from one of our offices.
Key Responsibilities
Serve as SME for controlled document management, ensuring compliant governance and inspection readiness
Author, review, approve, and manage controlled procedures and quality documents per GxP requirements
Drive document lifecycle management activities including creation, revision, periodic review, and archival
Provide guidance on procedural writing standards and document management best practices
Support GxP training governance to ensure compliance with regulatory requirements
Maintain effective training curricula aligned with role-based responsibilities and procedural updates
Monitor training compliance metrics and support remediation of non-compliant records
Support inspection readiness activities related to training documentation and personnel qualification
Lead regulatory compliance activities across global GxP operations
Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections
Monitor evolving regulatory requirements and implement compliance strategies
Support development of remediation plans for audit findings and compliance gaps
Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control
Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement
Support harmonization of quality processes to improve scalability and effectiveness
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field
8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech
Strong knowledge of FDA, EMA, ICH, and global GxP regulations
Experience supporting regulatory inspections and audit management
Hands-on experience with controlled document management and eDMS platforms
Experience with GxP training governance and learning management systems
Strong analytical, communication, and stakeholder management skills
Ability to manage multiple priorities in fast-paced environments
Experience in biologics, vaccines, or advanced therapeutics (preferred)
Experience supporting global compliance initiatives across multiple regions
Familiarity with Veeva Vault
Fluent in English written and spoken
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 22,000+ global employees 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 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 any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
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 22,000+ global employees 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 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 any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
