Regulatory Affairs Executive

1. Job Purpose

To ensure regulatory compliance for pharmaceutical products by preparing, reviewing, compiling, and submitting regulatory dossiers and documentation to the relevant regulatory authorities in accordance with applicable guidelines and requirements.

2. Key Responsibilities

Regulatory Documentation and Submissions

Prepare, compile, review, and maintain regulatory dossiers for pharmaceutical products.

Prepare and maintain Common Technical Document (CTD) and electronic CTD (eCTD) submissions, as applicable.

Prepare and review regulatory documents, including product registration dossiers, variations, renewals, and amendments.

Ensure accuracy, completeness, consistency, and timely submission of regulatory documents.

Coordinate with internal departments to collect required technical and supporting documents.

Regulatory Compliance

Ensure compliance with applicable regulatory guidelines, requirements, and pharmaceutical regulations.

Monitor changes in regulatory guidelines and communicate relevant updates to concerned departments.

Maintain regulatory trackers, submission records, product registrations, and approval databases.

Support regulatory inspections, audits, and compliance-related activities, as required.

Cross-Functional Coordination

Coordinate with Quality Assurance (QA), Quality Control (QC), Production, Research and Development (R&D), Analytical Development, and other relevant departments.

Follow up on pending documents and technical queries required for regulatory submissions.

Support the preparation and review of product information, labels, package inserts, and artwork for regulatory compliance.

Coordinate with regulatory consultants, distributors, and international affiliates, where applicable.

Regulatory Authority Correspondence

Assist in preparing responses to regulatory queries and deficiency letters.

Track submission status, approval timelines, renewals, and regulatory commitments.

Maintain records of regulatory approvals, licenses, certificates, and correspondence.

3. Required Skills and Competencies

Knowledge of pharmaceutical regulatory affairs and applicable regulatory guidelines.

Understanding of CTD/eCTD dossier preparation and lifecycle management.

Familiarity with regulatory submissions, product registrations, variations, and renewals.

Strong documentation, analytical, and organizational skills.

Good written and verbal communication skills.

Proficiency in MS Office and regulatory documentation systems.

Ability to coordinate with cross-functional teams and meet submission deadlines.

4. Educational Qualification and Experience

Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a relevant life-science discipline.

2–5 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.

Experience in domestic or international regulatory submissions will be an advantage.

5. Key Performance Indicators (KPIs)

Timely and accurate submission of regulatory dossiers.

Compliance with applicable regulatory requirements.

Timely responses to regulatory queries.

Effective tracking of product registrations, renewals, and variations.

Accuracy and completeness of regulatory documentation.

Timely closure of regulatory documentation gaps and commitments.

6. Preferred Experience

Experience with Indian regulatory authorities, including CDSCO and relevant State Licensing Authorities, or international authorities, depending on the assigned markets.

Exposure to generic formulations, APIs, or finished pharmaceutical products.

Knowledge of applicable ICH guidelines and pharmaceutical quality documentation.

Experience in regulatory lifecycle management and product change assessments.

Pay: ₹25,000.00 - ₹30,000.00 per month

Work Location: In person