Regulatory Affairs Executive / Associate (0–2 Years)

Job Description

The Regulatory Affairs Executive / Associate supports the preparation and submission of regulatory documents, ensuring compliance with national and international regulations for drug products.

Key Responsibilities

• Prepare and maintain regulatory submission dossiers (CTD/eCTD)

• Support product registration and approval processes

• Review product labeling and promotional materials for compliance

• Assist in responding to regulatory authority queries

• Maintain updated knowledge of applicable regulations and guidelines

• Ensure documentation and record-keeping as per SOPs

Skills & Requirements

• B.Pharm / M.Pharm / Life Sciences graduate

• Basic understanding of regulatory guidelines (FDA, EMA, CDSCO, ICH)

• Attention to detail and strong documentation skills

• Good communication and teamwork skills