Regulatory Affairs Manager at Fidson Healthcare Plc

Fidson Healthcare Plc, proudly Nigerian, is a leading pharmaceutical company which has evolved from being a distributor for multinationals in 1995 to full-fledged manufacturing, sales and marketing company with a strong brand. At Fidson, we support each other to greatness. We not only inspire our people to achieve, but we also celebrate their achievements with them. Together, we work and play hard.

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Manager

Location: Obanikoro, Lagos
Employment Type: Full-time

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.

Application Closing Date
15th August, 2024.