Our client, a dedicated Pharmaceutical company committed to excellence and compliance is recruiting to fill the position below:
Job Title: Regulatory Affairs Officer
Location: Lagos
Description
- Our client is a dedicated pharmaceutical company seeking a Regulatory Affairs Officer to ensure full compliance with regulatory requirements and provide crucial support in the planning and coordination of regulatory activities.
Key Responsibilities
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- Gather information and documents for new product registrations, formula changes, and variations in existing products. Submit these to NAFDAC and other relevant authorities for approval.
- Monitor product registrations and ensure timely renewal of existing product approvals.
- Compile product dossiers received from manufacturers in formats acceptable to regulatory agencies.
- Assist in preparing and submitting regulatory agency applications, reports, and correspondence.
- Contribute to the development of regulatory strategies and implementation plans for new product submissions.
- Handle online applications for API permits, Excipient permits, Narcotic permits, and other relevant permits in the single trade portal.
- Support in coordinating and monitoring clinical studies of the company’s products.
- Keep other company departments informed about regulatory requirements.
- Ensure timely submissions and approvals of applications according to regulatory plans and strategies.
- Review marketing materials, information leaflets, and packaging artworks to meet regulatory agency requirements.
- Ensure regulatory compliance in advertisements and secure approval for planned promotional materials.
- Communicate regulatory issues with the Regulatory Affairs Manager and other related departments, formulating appropriate responses.
- Assist in audits, regulatory agency inspections, and product recalls.
- Assist in coordinating the destruction of expired and rejected products and materials.
- Document reported Adverse Drug Reactions and enforce pharmacovigilance compliance related to assigned products.
- Support documentation efforts to ensure compliance with domestic and international regulations and standards.
- Register company premises, Superintendent Pharmacist, and key Organizational Managers with the Pharmacists Council of Nigeria (PCN).
- Represent the department in QMS and cGMP activities.
- Coordinate QMS and cGMP documentation, implementation, and audit-related activities within the department.
- Disseminate information on QMS and cGMP implementation to department staff.
- Complete Corrective Action and Preventive Action Plans for gaps identified during inspections and ensure their closure.
- Provide assistance to external auditors in compliance reviews.
- Participate in internal audits, contribute to report writing, and make presentations at monthly meetings as needed.
Requirements
- Interested candidates should possess a Bachelor’s Degree in relevant fields with 0 – 3 years work experience.
Application Closing Date
11th December, 2023.
Deadline: December 11, 2023
Job Features
Job Category | Regulatory Affairs Officer |