Regulatory Affairs Manager at Fidson Healthcare Plc

Key Responsibilities

• Interface with Regulatory Authorities
• Supervise Product registration at NAFDAC & other relevant regulatory bodies.
• Development and monitoring of KPIs for Regulatory Affairs processes
• Monitors regulatory activities.
• Participation and follow through of Regulatory inspections.
• Generation, implementation, and monitoring of CAPAs
• Current Good Manufacturing Practice process coordination & follow-ups
• Product dossiers, SMPC and inserts reviews.
• Annual Pharmacist and Premises License registration.
• Review of Product artwork vetting in compliance with regulatory standards and company approval
• Provide disposition of physical examination of imported products delivered at the warehouse for sales.
• Coordination of the inspections of the warehouses & depots to ensure GMP/GDP compliance.
• Annual import and clear permits processing
• End User Certificate processing.
• Review and Documentation and statistical analysis of annual Post Marketing Surveillance.
• Monitoring, follow-up, and Documentation of Customer Complaints.
• Monitor implementation and compliance of Quality/ Environmental Management System (QMS/EMS) activities.
• Regulatory policy and Intelligence reporting
• Export product Registration and Monitoring
• Follow up and support on Expression of Interest being submitted by Fidson.
• Regulations/Regulatory Policies update and documentation
• Monitoring and review of Poisons Record Update
• Participate & follow upon Product Recall exercises.
• Follow up on Product recall with relevant Regulatory bodies.
• Supervision and resolution of issues on electronic costing/Stamping process for clearing of consignment/documents.
• Trademark & Packdesign Registration
• Follow up on Distributor accreditation.
• Patent registration.
• Review SOPs for the unit and other departments at the HO.
• Ad-hoc as may be required.

Minimum Educational Requirements

• Candidates should possess HND / B.Sc / B.Pharm Degrees with 8+ years relevant work experience.

Required Competency and Skills:

• Communication skill
• Interpersonal and relationship-building skills
• Good Initiative
• Good organization
• Time management
• Leadership skills
• Proficiency in Microsoft.