Require Executive / Sr. Executive - Drug Regulatory Affairs

Roles and Responsibilities

• Planning, compilation, review and submission of dossiers related to export.
• Review of labels of Drugs, Cosmetics and Medical Devices and ensuring their full compliance with the applicable Rules and Regulations.
• Handling and responding to all the product specific queries.
• Performing Root cause and analysis and preparing replies to the show cause notices
• Ensuring overall compliance with domestic regulatory requirements.
• Co-ordination with respective departments.
• Maintaining familiarity with company product ranges.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Ensuring that quality standards are met and submissions meet strict deadlines.
• Maintain high levels of accuracy, meet tight deadlines.
• Management of Data.
• Preparing DRA's MIS presentation (Quarterly basis) to management.
• Preparation and submission of DRA's Performance review plan (PRP) (Quarterly basis) to Management.
• Maintaining Product Registration Certificates received.
• Timely answering Queries raised by Health Authorities of respective countries and customers.

Required Candidate profile

Desired candidate profile

1. Candidate should be well versed with Drug and Cosmetics Act especially Rule 96 and 97

2. Candidate should have thorough knowledge of verifying IP

3. Candidate should be able to review the COAs received from various companies

4. Candidates should be able to review artworks related to Drugs, Cosmetics, Medical Devices, Ayurveda etc

5. Candidate should have good knowledge about Legal Metrology regulations