Job Description

Job Title:

Regulatory Affairs (RA) Executive / Officer

Experience:

1-5 years (Pharma Industry)

Qualification:

B.Pharm / M.Pharm / M.Sc.

Job Purpose

To prepare, review, and submit all regulatory documentation required for product registration and ensure compliance with local and international regulatory agencies (e.g., PICS, EU, ROW countries).

Key Responsibilities

Prepare and compile dossiers (CTD/eCTD, ACTD, country-specific formats) Coordinate with F&D, QA, QC, and Production teams to collect technical data Prepare and maintain Product Master Files (PMF), Site Master Files (SMF), Drug Master Files (DMF), and related documents Review and finalize Stability Data, Process Validation Reports, Specifications, and Test Methods Handle new product registrations, renewals, variations, and post-approval submissions Respond to regulatory queries and track submission timelines Ensure compliance with current regulatory guidelines (CDSCO, WHO, ICH, etc.) Maintain and update regulatory documentation databases and archives Support in obtaining and maintaining COPP, FSC, Manufacturing Licences, and Registration Certificates

Required Skills

Strong understanding of regulatory requirements and dossier preparation Proficiency in CTD/eCTD documentation Good knowledge of MS Office (Word, Excel, PowerPoint) Excellent communication and cross-department coordination skills High level of attention to detail and accuracy

Key Competencies

Analytical mindset with strong documentation precision Good organizational and project management abilities Ability to manage multiple regulatory submissions Team player with a proactive and responsible approach
Job Type: Full-time

Pay: ₹20,082.18 - ₹40,861.33 per month

Benefits:

Provident Fund
Work Location: In person