Regulatory Affairs Officer

The job holder is responsible for management and facilitation of registration related to Pharmaceutical, Veterinary and Medical. She/he builds relationship with regulatory authorities; coordinates with Logistic teams to provide regulatory input in order to obtain timely regulatory approvals for the products; handles quality related queries / complaints; and stays updated on regulatory aspects pertinent to business development.

 

Key Responsibilities

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

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• 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

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• 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.

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• 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.

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• 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

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• 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.

Bachelors Degree or Higher

Pharmacy background is preferred but not essential