About the role
Job Description
Prepare, review, and maintain regulatory documents and submissions in accordance with applicable regulatory guidelines and company procedures.
Compile and coordinate regulatory dossiers, applications, renewals, variations, amendments, and other regulatory submissions.
Review technical documents, product specifications, analytical data, stability data, and manufacturing information for regulatory compliance.
Coordinate with Quality Assurance, R&D, Production, and other departments to obtain regulatory information and documentation.
Review QA documents such as deviations, CAPA, change controls, SOPs, and batch-related documents for regulatory requirements and impact.
Prepare and coordinate responses to regulatory queries, deficiencies, observations, and requests for additional information.
Maintain regulatory trackers, submission records, approvals, licenses, certificates, and other regulatory documentation.
Support regulatory audits and inspections by preparing required documents and coordinating responses with the QA and relevant departments.
Monitor updates in regulatory guidelines and evaluate their impact on products, processes, documentation, and quality systems.
Ensure timely completion of regulatory activities while maintaining accuracy, compliance, proper documentation, and data integrity.
Requirements
Bachelor’s or Master’s degree in Pharmacy is mandatory.
Minimum three years experience in QA or analytical validation roles.
Hands-on experience reviewing analytical method validation documentation.
Should have good communication skills.
Strong analytical data interpretation and technical documentation review skills.
Benefits
Remote working option with defined review responsibilities.
Flexible working hours aligned to dossier and submission timelines.
High technical ownership without laboratory or shop-floor operations.