Regulatory Affairs 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.