Regulatory Affairs Officer at Alpha Pharma

Alpha Pharmacy Limited is recruiting for the position of a REGULATORY AFFAIRS OFFICER.

REQUIREMENTS.

• B.Pharm.  
• Minimum of 3 years of work experience as a regulatory officer.
• Should be familiar with agencies' compliance processes.

JOB DESCRIPTION.

• Product registration with NAFDAC, renewals, import permits, clearing permits (for Narcotics), Laboratory analysis requests, facility inspection requests, and product dossiers review.
• Obtaining permits for orphan products with NAFDAC under service drugs provisions; global listing licenses for food and cosmetics products.
• Pharmacovigilance (safety issues about our product. Collection of product ADRs and logging into pharmacovigilance logbook that is reported to NAFDAC.
• Monthly reconciliation report for each product we market which will be returned to the affected companies and NAFDAC Pharmacovigilance centre.
• Postmarketing surveillance – any additional information besides pharmacovigilance issues that concerns our product. E.g emergence of better molecules. New indications for existing products. New formulations such as incrementally modified drugs.
• Narcotic and controlled substances distribution monitoring and reporting.
• Monitoring of cold chain and temperature-controlled logistics systems.
• Interfacing with regulatory teams of the company’s foreign trade partners under the supervision of the regulatory affairs manager.