Regulatory Affairs Officer

Overview

• Complete registration formalities for Pharmaceutical, Veterinary and Medical
• Review regulatory documentation and technical product information
• Provide regulatory support for portfolio of products
• Establish and update registration database in the company
• Update licenses and collect information on registration instructions and regulations
• Provide and complete forms need in registration
• Complete forms and requests originating from government agencies (DM)
• Carry out all subsequent follow up and pricing negotiations necessary to obtain the approval
• Checking all import permits
• Maintain contact with regulatory authorities
• Communicate with regulatory bodies in DM & MOH to facilitate successful product launch.
• Establish healthy & effective relationship with all concerned personnel at DM.
• Provide the Logistic teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
• Update Logistic team on products for shipment.
• Ensure approval of import permits by DM.
• Deal with quality related questions and complaints
• Follow up and update all existing registration dossiers & handling minor change variations that crop up from time to time
• Ongoing visits and intensive call to all concern people
• Timely accurate solutions to all complaints
• Perform Pharma co-vigilance activities
• Prepare pharma co-vigilance SOPs as required by our principals.
• Train the company staff as per the SOPs.
• Follow up for any reported safety case.
• Providing required documentation to principals during occasional PV audits.