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