adminFidson Healthcare Plc, proudly Nigerian, has grown from a distributor for multinationals in 1995 into a leading pharmaceutical manufacturing, sales, and marketing company. With a strong brand presence, Fidson fosters a supportive environment where employees are inspired to achieve greatness. The company celebrates achievements collectively, promoting a culture of hard work and play.
We are hiring for:
Job Title: Regulatory Affairs Manager.
Location: Obanikoro, Lagos.
Contract 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 permit 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 the Poison 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.
Job Requirements
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.
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