JOB TITLE: REGULATORY AFFAIRS OFFICER
REPORTS TO HEAD OF REGULATORY AFFAIRS
LOCATION: LAGOS MAINLAND
as a liaison with regulatory agencies to ensure the appropriate licensing,
marketing, and legal compliance of pharmaceutical and medical products to
control the safety and efficacy of products.
prepare and review all appropriate documents, for example, CTD dossier and
submit them to regulatory authorities within a specified time frame.
be involved in all stages of drug development and after drug approval and
track of the ever-changing legislation in all the regions where the company
wishes to distribute its products.
in the Pharmacovigilance/Post Marketing surveillance of drugs.
KEY DUTIES AND
prepare, and review CTD dossiers.
Product registration with NAFDAC, monitoring and setting timelines for license variations and
renewal approvals, import
permits, clearing permits (for Narcotics), and facility inspection requests.
Liaising with and making presentations to regulatory authorities.
product, pack size extension, and other applications as needed.
communication of any compliance directive to the office for corrections.
EDUCATION & WORK EXPERIENCE
Minimum of Bachelor's degree in (Pharmacy,
Microbiology) or its
be conversant with the regulatory requirements for CTD Dossier submission and
possess vetting ability.
Minimum of 2-3 years of working experience as a Regulatory Officer involved in NAFDAC procedures of product
of 1-2 years’ experience in NAFDAC-regulated industries involved in importation