Shalina Healthcare is a market leader in making quality healthcare products affordable and available across Africa. We achieve this by sourcing from WHO-approved production facilities in India and China and by focusing on our first-class distribution expertise. Shalina Healthcare is privately owned and part of the Shalina Group.
Experience3 – 5 years
Location Lagos
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.
Method of Application
Interested and qualified? Go to Shalina Healthcare on www.linkedin.com to apply
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