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  • Posted: Oct 22, 2025
    Deadline: Not specified
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  • 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. We have been operating in...
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    Regulatory Affairs Pharmacist

    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.

    go to method of application ยป

    Production Pharmacist

    Job Summary

    • To ensure the efficient, compliant, and safe manufacturing of pharmaceutical products by supervising production activities, monitoring adherence to cGMP and regulatory requirements, and supporting continuous process improvement

    Key Responsibilities

    • Supervise and coordinate day-to-day production operations in accordance with approved SOPs, cGMP, and regulatory standards.
    • Ensure proper documentation of batch manufacturing records, logbooks, and related documents in compliance with GDP.
    • Monitor in-process operations to ensure quality, safety, and efficiency of production.
    • Conduct line clearance, equipment checks, and ensure proper cleaning and sanitization before and after production.
    • Collaborate with QA, QC, Engineering, and Supply Chain to ensure smooth production flow.
    • Train, guide, and monitor operators/technicians on production processes, hygiene, and safety practices.
    • Identify deviations, report non-conformances, and support implementation of corrective and preventive actions (CAPA).
    • Assist in validation and qualification of equipment, processes, and cleaning procedures.
    • Maintain strict compliance with EHS (Environment, Health & Safety) policies and ensure safe workplace practices.
    • Participate in audits (internal, external, regulatory) and ensure readiness of production area at all times.
    • Contribute to continuous improvement initiatives aimed at enhancing productivity, minimizing wastage, and optimizing resources.

    Key Performance Indicators (KPIs)

    • Compliance with cGMP and SOPs (zero critical deviations).
    • Batch rejection and rework rates.
    • Production yield and efficiency.
    • Timely completion of production schedules.
    • Audit readiness and compliance status.
    • Staff training and competency development.

    Qualifications & Experience

    • Bachelor of Pharmacy (B.Pharm) or Doctor of Pharmacy (Pharm.D).
    • Current registration with Pharmacists Council of [Country].
    • 2–5 years of experience in pharmaceutical production, preferably in [dosage forms: tablets, capsules, injectables, creams, etc.].
    • Strong knowledge of cGMP, GDP, and regulatory requirements (NAFDAC, WHO, FDA, etc.).
    • Proficiency in documentation and compliance with pharmaceutical manufacturing guidelines.

    Skills & Competencies:

    • Strong attention to detail and commitment to quality.
    • Good leadership, supervisory, and team management skills.
    • Excellent problem-solving and decision-making ability.
    • Strong communication and interpersonal skills.
    • Ability to work under pressure and meet production timelines.
    • Computer literacy (MS Office, ERP systems preferred).

    Method of Application

    Use the link(s) below to apply on company website.

     

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