Regulatory Officer at Geneith Pharmaceuticals Limited

• 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