• Develops strategies and procedures to ensure regulatory compliance.
• Ensure all legal and regulatory documents are filed and monitor compliance with laws and regulations.
• Responsible for authorisation of production, Batch Manufacturing Record (BMRs), and document review
• Make sure all professional activities undertaken by you or under your control are covered by adequate professional indemnity cover.
• Ensures Good Manufacturing Practice (GMP) is adhered to
• Registration of products with the National Agency for Food Drugs. Administration and Control (NAFDAC)
• Ensure that Production and manufacturing operations are carried out in compliance with the current WHO GMP, National Regulatory Authority Standard (NAFDAC, PCN, Federal Ministry of Labour and Productivity), and NIS ISO 9001:2015.
• Liaising with bodies such as the Pharmaceutical Group of the Manufacturers Association of Nigeria (PMGMAN), National Agency for Food Drugs Administration and Control (NAFDAC), Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), Federal and State Ministries of Health, Customs and Excise Authorities
• Handling of market complaints with QC/QA
• Oversee the registration and renewal of the premises license with the Pharmacist Council of Nigeria (PCN) annually as contained in chapter 152 of the pharmacy law.
• Oversee the activities of the regulatory unit as it concerns compliance, registration, and renewal of licenses.
• Stay abreast of GMP, Pharmacovigilance, and CGMP guidelines regarding product development and compliance
• Processing and obtaining chemical permit for Dana Group of companies
• Ensure that all legal and professional requirements covering operations in the premises are adhered to
• Guiding the management and internal clients to comply with regulatory requirements
• Participation in advocacy, public corporate responsibility programmes and maintains a cordial relationship with stakeholders in our business

Requirements

• Minimum of M.Pharm
• Must be a licensed Pharmacist
• 7 – 8 years’ experience in regulatory and production
• Excellent communication Skills
• Good negotiation and relationship management skills.