Senoir Officer - Regulatory Affairs

Drlogy; Ahmedabad District; Vor Ort; INR 500.000 - 1.000.000; Vollzeit

Zusammenfassung

Drlogy is seeking a Senior Officer in Regulatory Affairs responsible for preparing and submitting regulatory documents for pharmaceutical products. The role involves coordinating with QA, QC, production, R&D, and ensuring compliance with regulatory standards.

The ideal candidate will ensure timely approvals and market compliance while maintaining the confidentiality and accuracy of all related documentation. Comprehensive knowledge of dossier preparation and regulatory processes is essential.

Aufgaben

• Prepare, compile, and review regulatory dossiers for pharmaceutical product registration and approval.
• Support submission of regulatory documents as per applicable country-specific guidelines and requirements.
• Review product documents including specifications, COA, stability data, manufacturing records, and validation reports.
• Coordinate with QA, QC, production, R&D, and packaging teams for required regulatory documentation.
• Prepare responses to regulatory queries and ensure timely submission of requested information.
• Support filing of variations, renewals, amendments, and post-approval changes.
• Review labeling, artwork, product information, package inserts, and promotional materials for regulatory compliance.
• Maintain regulatory databases, submission trackers, approval records, and product registration documents.
• Ensure documentation complies with CTD, ACTD, country-specific formats, and applicable regulatory standards.
• Monitor changes in regulatory guidelines and communicate relevant updates to internal teams.
• Support preparation of technical documents for domestic and international market submissions.
• Coordinate with external consultants, distributors, and regulatory agencies when required.
• Maintain confidentiality and accuracy of all regulatory documents and product information.
• Assist in internal audits, regulatory inspections, and compliance review activities.
• Ensure timely completion of regulatory tasks to support business, manufacturing, and market launch plans.

Jobbeschreibung

The Senior Officer – Regulatory Affairs will be responsible for preparing, reviewing, compiling, and submitting regulatory documents for pharmaceutical products in compliance with applicable national and international guidelines. This role requires knowledge of dossier preparation, product registration, variation filing, regulatory queries, labeling compliance, and coordination with QA, QC, production, R&D, and external regulatory authorities to support timely approvals and market compliance.

Responsibilities

• Prepare, compile, and review regulatory dossiers for pharmaceutical product registration and approval.
• Support submission of regulatory documents as per applicable country-specific guidelines and requirements.
• Review product documents including specifications, COA, stability data, manufacturing records, and validation reports.
• Coordinate with QA, QC, production, R&D, and packaging teams for required regulatory documentation.
• Prepare responses to regulatory queries and ensure timely submission of requested information.
• Support filing of variations, renewals, amendments, and post-approval changes.
• Review labeling, artwork, product information, package inserts, and promotional materials for regulatory compliance.
• Maintain regulatory databases, submission trackers, approval records, and product registration documents.
• Ensure documentation complies with CTD, ACTD, country-specific formats, and applicable regulatory standards.
• Monitor changes in regulatory guidelines and communicate relevant updates to internal teams.
• Support preparation of technical documents for domestic and international market submissions.
• Coordinate with external consultants, distributors, and regulatory agencies when required.
• Maintain confidentiality and accuracy of all regulatory documents and product information.
• Assist in internal audits, regulatory inspections, and compliance review activities.
• Ensure timely completion of regulatory tasks to support business, manufacturing, and market launch plans.