Regulatory Affairs Consultant – Compliance & Process
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
Controlled Document Management & Governance
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
Training Governance & Compliance
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
Regulatory Compliance & Inspection Readiness
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
Quality Systems & Operational Excellence
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
Skills and Experience required for the role:
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
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
Controlled Document Management & Governance
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
Training Governance & Compliance
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
Regulatory Compliance & Inspection Readiness
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
Quality Systems & Operational Excellence
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
Skills and Experience required for the role:
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