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

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.

Bachelors Degree or Higher

Pharmacy background is preferred but not essential