Regulatory Affairs Manager at Estrada International Staffing Solutions

About The Job

• Our client is seeking to hire a Regulatory Affairs Manager who will be responsible for planning, directing, and coordinating regulatory compliance activities to ensure the company adheres to the requirements of relevant authorities, particularly NAFDAC and the Pharmacist Council of Nigeria (PCN).

What You’ll Do

• Ensure up-to-date registration with the Pharmacist Council of Nigeria (PCN).
• Prepare and submit regulatory applications, reports, and correspondence.
• Develop and implement strategies for product registration and renewal.
• Respond to regulatory inquiries and ensure compliance with standards.
• Review and approve product materials to meet regulatory requirements.
• Manage audits, inspections, product recalls, and permit acquisition.
• Represent the company in industry meetings (e.g., NIROPHARM, PMGMAN).

Key Qualifications

• Bachelor’s degree in Pharmacy (B.Pharm) or a related field.
• Minimum of 8 years of regulatory experience in the pharmaceutical industry.
• Strong knowledge of NAFDAC, PCN, and other relevant regulatory bodies' requirements and processes. Experience in handling product registrations, renewals, and compliance audits.
• Proven ability to liaise with regulatory authorities and represent the company in industry meetings.
• Familiarity with international pharmaceutical regulations (e.g., WHO GMP, FDA, EMA) is an added advantage.
• Strong analytical, documentation, and problem-solving skills.