Regulatory Affairs Consultant – Compliance & Process

Responsibilities

• Serve as a Subject Matter Expert (SME) for controlled document management, ensuring compliant governance and inspection readiness.
• Author, review, approve, and manage controlled procedures and quality documents in accordance with GxP requirements.
• Drive document lifecycle management activities, including creation, revision, periodic review, and archival.
• Support GxP training governance by maintaining effective training curricula aligned with role-based responsibilities.
• Monitor training compliance metrics and support the remediation of non-compliant records.
• Lead regulatory compliance activities and drive inspection readiness initiatives for FDA, EMA, MHRA, and other health authorities.
• Manage Quality Management System (QMS) processes, including deviations, CAPAs, change controls, and SOP management.
• Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field.
• 8+ years of experience in Regulatory Compliance, Quality Assurance, or related GxP functions within the pharma/biotech industry.
• Strong knowledge of FDA, EMA, ICH, and global GxP regulations.
• Proven 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 (LMS).
• Proficiency in English (written and spoken).
• Strong analytical, communication, and stakeholder management skills.

Preferred Qualifications

• Experience in biologics, vaccines, or advanced therapeutics.
• Experience supporting global compliance initiatives across multiple geographic regions.
• Familiarity with Veeva Vault.

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We are dedicated to advancing science with expertise and empathy, ensuring that life-changing products reach the patients who need them most. We offer a supportive, inclusive, and flexible work environment that fosters professional growth and global collaboration.