Regulatory Officer

We are seeking a detail-oriented and proactive Regulatory Officer to ensure compliance with all applicable regulatory standards. The candidate will be responsible for preparing regulatory submissions, maintaining documentation, coordinating across departments, and ensuring that company processes and products meet regulatory requirements.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers and documents to authorities (e.g., CDSCO, FDA, BIS, pollution control boards).
• Manage product licensing, registration, and renewal processes.
• Maintain regulatory documentation, compliance records, and databases.
• Ensure all product labels, packaging, and artworks comply with regulatory norms.
• Coordinate with QA/QC, R&D, Production, and Purchasing teams for required documentation.

• Monitor updates and changes in regulatory guidelines and implement necessary actions.

• Support audits, inspections, and responses to regulatory authority queries.
• Draft SOPs, technical compliance documents, and reports.
• Assist in ensuring compliance with GMP, ISO, and other quality standards.

Skills & Competencies

• Strong knowledge of regulatory processes and compliance requirements.
• Excellent documentation and technical writing skills.
• Good understanding of regulatory authority portals and submission processes.
• High attention to detail and accuracy.
• Strong communication and coordination capabilities.
• Ability to handle multiple assignments and meet deadlines.

Preferred Attributes

• Experience in regulatory affairs within the pharmaceutical or chemical industry.

• Knowledge of national and international guidelines (GMP, ISO, WHO, BIS, etc.).

• Prior experience with regulatory audits and inspections.