Executive – Regulatory Affairs

Job Summary:

We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access and product lifecycle management.

The ideal candidate will have strong knowledge of regulatory guidelines, documentation practices, and submission processes applicable to [pharma / medical device / FMCG] industries.

Key Responsibilities:

• Prepare, compile, and review regulatory documents and dossiers for submission to national and international health authorities.
• Ensure timely submission, approval, and renewal of product registrations, licenses, and certificates.
• Maintain regulatory databases, tracking systems, and documentation for all assigned products.
• Support new product launches, variations, and post-approval changes by coordinating with cross-functional teams (QA, QC, R&D, Production).
• Review and approve product labeling, artwork, and promotional materials for regulatory compliance.
• Keep abreast of latest regulatory requirements, notifications, and updates from relevant authorities (CDSCO, FDA, EMA, WHO, etc.).
• Coordinate with regulatory agencies, consultants, and partners for submissions and clarifications.
• Participate in audits and inspections, providing required documentation and responses.
• Ensure compliance with Good Regulatory Practices (GRP) and company SOPs.
• Support regulatory intelligence activities and contribute to process improvements.