We are seeking to hire a meticulous and knowledgeable Regulatory Compliance Officer to ensure that their pharmaceutical products meet all applicable regulations, guidelines, and industry standards.
The candidate will be responsible for overseeing regulatory compliance, ensuring adherence to Good Manufacturing Practices (GMP), and maintaining current knowledge of evolving regulations.
Key Responsibilities
Develop and implement regulatory strategies to ensure compliance with local pharmaceutical regulations.
Manage and oversee the submission of regulatory documents for the approval and registration of new products, variations, and renewals.
Monitor the company’s activities to ensure compliance with regulations (NAFDAC) and industry standards.
Prepare, review, and submit regulatory dossiers, reports, and other required documentation to regulatory bodies.
Serve as the primary point of contact for regulatory inspections, audits, and assessments. Ensure corrective and preventive actions are taken where needed.
Conduct compliance risk assessments for new and existing products, processes, and facilities.
Maintain effective communication and relationships with national regulatory authorities.
Assist in the development of internal policies and procedures to ensure compliance with new and existing regulations.
Educate and train staff on regulatory requirements and compliance protocols.
Maintain a comprehensive and organized database of regulatory documents, approvals, and correspondence.
Qualifications
Education: Bachelor’s Degree in Pharmacy, Biochemistry, Chemistry or related field.
Experience: 3-5 years of experience in regulatory affairs or compliance (NAFDAC).
Key Competencies
Regulatory Knowledge: Up-to-date with pharmaceutical regulatory environments and able to interpret and apply regulations to ensure compliance.
Ethical Judgment: Ensure all practices adhere to ethical and regulatory standards.