Regulatory Affairs Manager

This position offers a great opportunity for career growth. Job Purpose The Regulatory Affairs Manager is responsible for ensuring full regulatory compliance of all DKT products, operations, and activities in Nigeria. The role serves as the primary liaison with regulatory authorities, leads product registration and licensing activities, oversees pharmacovigilance and quality compliance, and provides strategic regulatory guidance to internal stakeholders to support safe, effective, and compliant program delivery. Key Responsibilities: Regulatory Compliance & Liaison

• Maintain effective working relationships with regulatory authorities including NAFDAC, the Pharmacists Council of Nigeria (PCN), and other relevant government agencies.

• Ensure full compliance with applicable pharmaceutical, medical device, public health, and donor-specific regulatory requirements.

• Monitor changes in regulatory laws, guidelines, and policies and proactively advise management on potential operational and business impacts.

• Track regulatory timelines and ensure proactive planning to avoid product or license lapses.

Licensing, Inspections & Regulatory Audits

• Ensure all required pharmaceutical licenses, permits, certifications, and approvals are obtained and remain valid at all times.

• Act as the designated Superintendent Pharmacist for regulatory and operational purposes, where required.

• Coordinate, support, and host regulatory inspections, audits, and site visits by NAFDAC, PCN, and other authorities.

• Address regulatory queries, inspection observations, deficiencies, and corrective or preventive actions in a timely and effective manner.

Pharmacovigilance & Quality Assurance

• Oversee the collection, evaluation, analysis, and reporting of adverse events in compliance with regulatory and donor requirements.

• Ensure maintenance of accurate, complete, and compliant documentation throughout the product lifecycle.

• Conduct risk assessment and management activities to ensure product safety, efficacy, and regulatory compliance.

• Support and participate in audits and inspections related to pharmacovigilance and quality systems.

Internal Advisory, Risk Management & Compliance Oversight

• Provide regulatory guidance and support to commercial, program, supply chain, and marketing teams.

• Review promotional, educational, and marketing materials to ensure compliance with regulatory and ethical standards.

• Identify regulatory and compliance risks and proactively recommend mitigation strategies.

• Support regulatory aspects of donor-funded projects, partnerships, and grants.

Documentation, Reporting & Process Improvement

• Maintain accurate and complete re...