Regulatory Affairs (RA) Executive / Officer

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