JOB TITLE: REGULATORY AFFAIRS OFFICER

REPORTS TO HEAD OF REGULATORY AFFAIRS

LOCATION: LAGOS MAINLAND

JOB BRIEF/SUMMARY

·         Act 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.

·         Coordinate, prepare and review all appropriate documents, for example, CTD dossier and submit them to regulatory authorities within a specified time frame.

·         To be involved in all stages of drug development and after drug approval and marketing.

·         Keep track of the ever-changing legislation in all the regions where the company wishes to distribute its products.

·         Involved in the Pharmacovigilance/Post Marketing surveillance of drugs.

KEY DUTIES AND RESPONSIBILITIES

·         Coordinate, 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.

·         Processing product, pack size extension, and other applications as needed.  

·         Prompt communication of any compliance directive to the office for corrections.

EDUCATION & WORK EXPERIENCE

·         Minimum of Bachelor's degree in (Pharmacy, Microbiology) or its equivalent.

·         Should 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 registration.

·         Minimum of 1-2 years’ experience in NAFDAC-regulated industries involved in importation