Regulatory Affairs Manager at DKT International

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 regulatory records, files, and correspondence.
• Prepare and submit regulatory and compliance reports for management as required.
• Develop, implement, periodically review, and train staff on regulatory, quality, and pharmacovigilance SOPs and processes.
• Lead initiatives to drive continuous improvement, operational efficiency, and high standards of quality and safety.
• Collate, escalate, and communicate regulatory and safety reports to relevant internal business units.

Vendor & Supplier Management

• Support the qualification, evaluation, and approval of overseas manufacturers to ensure that all imported products comply with Nigerian regulatory, quality, and safety requirements, applicable to DKT operations.

Other Responsibilities

• Perform any other duties reasonably required for the effective execution of the role and achievement of organizational objectives.

Qualifications & Experience

• Bachelor’s degree in Pharmacy or other relevant Life Sciences discipline.
• Must be a licensed Pharmacist with the Pharmacists Council of Nigeria (PCN) or an equivalent recognized regulatory body.
• A valid Superintendent Pharmacist licence, available for use by the company for regulatory and operational purposes, is mandatory.
• Membership of relevant professional bodies is an added advantage.
• Minimum of 10 years’ post-qualification experience as a Pharmacist, including 6–8 years of progressive experience in regulatory affairs, pharmacovigilance, quality assurance, and regulatory compliance within the pharmaceutical, healthcare, or FMCG sector.
• Proven experience working directly with NAFDAC and other regulatory agencies.
• Experience within an NGO or social marketing environment is an added advantage.

Key Competencies

• Strong knowledge of Nigerian pharmaceutical and public health regulatory frameworks.
• Excellent communication, negotiation, and stakeholder management skills.
• High attention to detail with strong documentation and reporting abilities.
• Ability to work independently, prioritize effectively, and manage multiple regulatory demands simultaneously.

Key Performance Indicators (KPIs)

• Regulatory Compliance: Zero critical regulatory non-compliance findings or sanctions from NAFDAC, PCN, or other authorities.
• Licensing & Registration: 100% validity of product registrations, licenses, and permits, with all new registrations, renewals, and variations submitted on time.
• Inspections & Audits: Successful regulatory inspections with no major or critical observations, and timely closure of all findings and CAPAs.
• Pharmacovigilance: 100% on-time submission of adverse event and safety reports, with a fully compliant pharmacovigilance system maintained.
• Process Improvement: SOPs reviewed at least annually, with measurable improvements in regulatory efficiency and reduced approval delays or rework.