Senior Regulatory Compliance Officer at Givanas Group of Companies

Job Overview

• 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.