Regulatory Pharmacist at Shalina Healthcare

Job 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 documentation

Qualifications and Experience

• Minimum Education: B. Pharm .
• License: Must be a registered and licensed Pharmacist with PCN
• Experience: Minimum of 3-5 years in regulatory affairs and pharmaceutical production

Skills:

• Strong knowledge of Nigerian pharmaceutical regulations
• Excellent communication and documentation skills
• Ability to manage compliance and regulatory audits
• Familiarity with GMP, CGMP, and pharmacovigilance practices