Clinical Audit Coordinator – Regulatory Compliance

Job Summary

We are looking for a motivated and detail-oriented Clinical Audit Coordinator to support our Regulatory Quality & Compliance team. This is an ideal opportunity for recent graduates in Pharmacy, Clinical Research, Pharmacology, or Life Sciences to begin a career in clinical quality and regulatory audits. The role focuses on supporting audits conducted under GxP frameworks, including GCP, GLP, and GVP.

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Key Responsibilities

• Assist in planning, scheduling, and coordinating regulatory audits (GCP/GLP/GVP), including internal, external, sponsor, and regulatory inspections.

• Support pre-audit document collection and preparation, including clinical trial documentation, SOPs, and training logs.

• Help prepare audit materials: audit agendas, logistics checklists, and audit team communications.

• Maintain and update audit trackers, audit logs, and regulatory compliance records.

• Communicate effectively with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, quality) to ensure timely responses and document submissions.

• Assist in drafting audit summary reports, documenting findings, and tracking Corrective and Preventive Actions (CAPAs).

• Support document archival and ensure adherence to ALCOA+ principles for data integrity.

• Stay informed of evolving global regulatory requirements related to GCP, GLP, GVP, and data privacy (e.g., ICH, FDA, EMA, CDSCO).

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Required Qualifications & Skills

• Bachelor’s degree in Pharmacy, Life Sciences, Pharmacology, or Clinical Research.

• Strong communication (written and verbal) and organizational skills.

• Basic understanding of clinical trial processes, regulatory frameworks, and GxP principles.

• Proficiency in Microsoft Office (Word, Excel, Outlook); exposure to quality or document management systems is a plus.

• Strong attention to detail and ability to follow procedures with discipline and accuracy.

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Preferred Attributes

• Eagerness to learn and grow in clinical quality and regulatory compliance roles.

• Exposure to GCP/GLP/GVP principles during coursework or internships is an added advantage.

• Ability to handle confidential information responsibly and ethically.

• A team player with a strong work ethic, problem-solving mindset, and adaptability in a fast-paced environment.

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Benefits

• Structured training in clinical quality and regulatory compliance.

• Mentorship from experienced audit and quality professionals.

• Career growth opportunities across QA, Regulatory Affairs, and Clinical Operations.

• Dynamic and collaborative work culture focused on excellence and compliance.