Jr. Officer- Regulatory

Department: Regulatory Affairs
Location: Bangalore, Electronic City
Experience: 0-3 years
Required Qualifications: BAMS (Mandatory)

Job Role:
Liaison with Ayush department and FSSAI department. Responsible for preparation and submission of applications for Manufacturing and loan license, product license, various certificates (non-conviction, free sale, performance etc.), submission of returns to FSSAI and raw material consumption details to NMPB, providing advice about regulations to Quality, Marketing and R&D teams

Required Skills:

• Thorough knowledge of Drugs and Cosmetics Act 1940 and Rules 1945.
• Thorough knowledge of FSSAI regulations.
• Communication skills.
• Good knowledge of other relevant regulations pertaining to food and medicines.

Role & responsibilities

1. Regulatory Compliance – AYUSH:

• Prepare and submit applications for new and renewal of manufacturing licenses, GMP certificates, and loan licenses.
• Handle applications for product licenses, free sale certificates, market standing, and performance certificates.
• Respond to notices from Drug Inspectors and coordinate during inspections.
• Ensure all products and packaging meet applicable AYUSH regulatory standards.

2. Regulatory Compliance – FSSAI:

• Manage applications for new and renewal of FSSAI manufacturing and product licenses.
• File quarterly FSSAI returns as per regulatory timelines.
• Ensure FSSAI compliance for product labeling, packaging, and ingredients.

3. NMPB Compliance:

• Submit annual raw material consumption reports to the National Medicinal Plants Board (NMPB).

4. Regulatory Documentation and Customer Support:

• Handle customer queries related to HHP (Human Health Products).
• Maintain control over product specifications for both AHP (Animal Health Products) and HHP.
• Conduct weekly reviews of Shakun regulatory updates and ensure timely updates on the GTCMS portal.

Key Performance Indicators (KPIs):

• Timely submission and approval of regulatory applications and renewals.
• Compliance rate with AYUSH, FSSAI, and NMPB regulations.
• Timely and accurate responses to regulatory inspections and notices.
• Reduction in customer query resolution time.
• Accuracy and completeness of filings and documentation.