Regulatory Pharmacist

Job Overview


Formulate strategies and procedures to ensure regulatory compliance.
Guarantee all legal and regulatory documents are filed and monitor adherence to laws and regulations.
Accountable for authorizing production, Batch Manufacturing Records (BMRs), and document review
Ensure all professional activities undertaken by you or under your supervision are covered by adequate professional indemnity insurance.
Guarantee Good Manufacturing Practice (GMP) is followed
Handle product registration with the National Agency for Food Drugs Administration and Control (NAFDAC)
Ensure that Production and manufacturing operations comply with current WHO GMP, National Regulatory Authority Standards (NAFDAC, PCN, Federal Ministry of Labour and Productivity), and NIS ISO 9001:2015.
Interact with organizations 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
Manage market complaints in collaboration with QC/QA
Supervise the registration and renewal of premises (Including Warehouse) licenses with the Pharmacist Council of Nigeria (PCN) annually as stipulated in chapter 152 of the pharmacy law.
Oversee regulatory unit activities concerning compliance, registration, and license renewals.
Keep up-to-date with GMP, Pharmacovigilance, and CGMP guidelines regarding product development and compliance
Process and obtain chemical permits for Dana Group of companies
Ensure adherence to all legal and professional requirements governing operations on the premises
Guide management and internal clients in complying with regulatory requirements
Participate in advocacy, public corporate responsibility programs and maintain cordial relationships with business stakeholders
Minimum of M.Pharm degree required
Must be a registered Pharmacist
5 years of experience in regulatory and production
Excellent communication Skills