Regulatory Affairs Officer
Core
Managing pharmaceutical, veterinary, and medical product registrations and liaising with regulatory authorities to obtain approvals.
Role type
Regulatory Affairs Officer
Builds
Regulatory dossiers, import permits, and product registration approvals for pharmaceutical, veterinary, and medical products.
Domain
Healthcare / Pharmaceuticals / Veterinary
Deliverable
client delivery
Required skills
Regulatory documentation review, database management, import permit processing, quality complaint handling, pharmacovigilance activities, SOP development, stakeholder communication
Preferred skills
Pharmacy background
Technologies
Regulatory databases
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; 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; 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.