Regulatory Executive

Talent Corner Hr Services; Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

Talent Corner Hr Services is seeking a regulatory affairs professional in Mumbai to manage the preparation and submission of regulatory dossiers, obtain product permissions, and ensure compliance with CTD/ACTD or eCTD requirements.

You will handle variations and renewals, respond to queries from regulatory agencies, review labeling and artworks, maintain regulatory databases, and stay updated on current regulatory requirements. Collaboration with PV and project teams is essential.

Responsibilities

• Follow up with Manufacturer for the documents as per the regulatory guidelines & preparation, compilation of dossiers for submission
• Knowledge of obtaining product permissions, COPP etc.
• Submit the product registration dossier of assigned products to targeted countries as per CTD/ ACTD or eCTD requirements
• File all the required variations and renewals, of assigned products in line with guidelines and checklists as per the plan.
• Respond to queries received from regulatory agencies or business units by ensuring complete and accurate information is provided within predefined timelines.
• Review product labeling, artworks, proof reading etc.
• Maintain various data bases in timely manner.
• Update himself/herself with the relevant & current regulatory requirement of various bodies.
• Provide required support to PV team as and when required
• Ensure support in execution of any projects assigned as per the business needs.

Job description

Key Roles and Responsibilities:

• Follow up with Manufacturer for the documents as per the regulatory guidelines & preparation, compilation of dossiers for submission
• Knowledge of obtaining product permissions, COPP etc.
• Submit the product registration dossier of assigned products to targeted countries as per CTD/ ACTD or eCTD requirements
• File all the required variations and renewals, of assigned products in line with guidelines and checklists as per the plan.
• Respond to queries received from regulatory agencies or business units by ensuring complete and accurate information is provided within predefined timelines.
• Review product labeling, artworks, proof reading etc.
• Maintain various data bases in timely manner.
• Update himself/herself with the relevant & current regulatory requirement of various bodies.
• Provide required support to PV team as and when required
• Ensure support in execution of any projects assigned as per the business needs.