Regulatory Affairs Officer at Alpha Pharma

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
3 years ago

Additional Details

Job ID
8646
Job Views
490

Job Description



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.


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