Regulatory Affairs Pharmacist

About Shalina Healthcare:We are one of the largest, privately owned pharmaceutical businesses across Africa (Global Head Quarters- Dubai, UAE) with recent forays across multiple, new lines of businesses, viz., Digital Healthcare, Diagnostics, Consumer Healthcare, etc.Over the last 40 years, operating across multiple geographies, we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory, respiratory, gastrointestinal, nutrition, oral care, dermatology, sexual well-being, and antiseptic liquids & soaps. Leading brands, great teams and a focus on influencing the well-being of people have made Shalina a household name in Africa.We have a track record few can match, and our brands are among the most trusted in Africa. We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities that we serve; people who identify with our Core Values and are as passionate about our Mission as we are.Website http://www.shalina.com/Role : Regulatory PharmacistDepartment: Manufacturing / ProductionReporting to : Head – Plant Operations / Factory ManagerLocation : NigeriaJob Summary:The Regulatory Pharmacist is responsible for ensuring that all pharmaceutical manufacturing operations comply with national and international regulatory standards. This includes overseeing product registration, ensuring Good Manufacturing Practice (GMP), and liaising with regulatory bodies such as NAFDAC, PCN, and PSN.Key Responsibilities:Develop and implement strategies to ensure regulatory compliance across all operations.Register pharmaceutical products with NAFDAC and ensure timely renewals.Ensure production and manufacturing activities comply with WHO GMP, NAFDAC, PCN, Federal Ministry of Labour, and NIS ISO 9001:2015 standards.Review and authorize Batch Manufacturing Records (BMRs) and other production documentation.Liaise with regulatory bodies including NAFDAC, PCN, PMGMAN, and relevant government ministries.Oversee the registration and renewal of premises licenses (including warehouses) with PCN.Handle market complaints in collaboration with Quality Control (QC) and Quality Assurance (QA) teams.Monitor and interpret changes in regulatory guidelines and ensure internal compliance.Guide internal teams and management on regulatory requirements and best practices.Ensure all professional activities are covered by adequate professional indemnity.Participate in advocacy and corporate responsibility programs to maintain stakeholder relationships.Process and obtain chemical permits and other regulatory documentationQualifications and ExperienceMinimum Education: B. Pharm .License: Must be a registered and licensed Pharmacist with PCNExperience: Minimum of 3-5 years in regulatory affairs and pharmaceutical productionSkills:Strong knowledge of Nigerian pharmaceutical regulationsExcellent communication and documentation skillsAbility to manage compliance and regulatory auditsFamiliarity with GMP, CGMP, and pharmacovigilance practices