- Prepare, review, and maintain regulatory submissions and documentation in compliance with applicable regulatory guidelines.

- Coordinate preparation of dossiers, variations, renewals, amendments, and other regulatory submissions.

- Review product documentation, specifications, analytical data, stability data, and manufacturing information for regulatory compliance.

- Work closely with Quality Assurance, Quality Control, R&D;, Production, and other cross-functional teams for regulatory requirements.

- Ensure regulatory documents are accurate, complete, properly controlled, and submitted within defined timelines.

- Support responses to regulatory queries, deficiencies, observations, and requests for additional information.

- Maintain regulatory databases, submission trackers, licenses, certificates, approvals, and related records.

- Review and assess QA-related documents, deviations, CAPA, change controls, SOPs, and quality documentation for their regulatory impact.

- Monitor changes in regulatory guidelines and assess their impact on existing products, processes, and documentation.





- Support regulatory audits and inspections by coordinating required documents, responses, and compliance-related activities.

Requirements

- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related discipline is mandatory.

- Minimum five years of experience in Quality Assurance, can consider candidates who have worked on manufacturing units and has handled market complaints.

- Solid knowledge of finished product specifications, analytical methods, and pharmaceutical laboratory testing practices.

- Working understanding of analytical method validation principles and regulatory requirements for laboratory testing.

- Ability to review analytical documentation and technical manufacturing data and coordinate effectively with R&D;, QC, QA, and regulatory teams.

Benefits

- Option to work from home or from office depending on operational requirements.

- Exposure to regulatory operations and pharmaceutical product submission processes across multiple markets.

- Opportunity to work closely with manufacturing, analytical laboratories, and regulatory teams.

📌 Assistant Manager - Regulatory Affairs (Dehradun)
🏢 Rhydburg
📍 Dehradun