Regulatory Affairs Officer at Alpha Pharmacy & Stores Limited

Alpha-Pharma has a commitment to mankind, a commitment of improving the quality of life for each and every individual through which we constantly strive to innovate, improve and increase the availability of cost-efficient generic medicines to the global market. We believe that medicine should be available to all people regardless of their location, and affordable for them at any income level such that the cost of medical treatment should not be a concern for any part of the population.

Through our commitment we have chosen to focus our resources on generic medicines in which field we aim to increase the availability of our quality medicines and increase global awareness of the vast financial savings offered to society by making generic medicines available to the general population.

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Officer

Location: Lagos

Responsibilities

• 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.

Requirements

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

Application Closing Date
Not Specified.