The Regulatory Affairs Manager is responsible for managing all regulatory activities of the company to ensure compliance with applicable pharmaceutical regulations and requirements. The role involves coordinating product registrations, regulatory submissions, license renewals, regulatory inspections and maintaining effective communication with regulatory authorities to ensure continuous market authorization and compliance of pharmaceutical products.
Major Responsibilities:
Develop and implement regulatory strategies to support product registration, market authorization and business objectives.
Prepare, review and submit regulatory dossiers, applications, variations and renewals to regulatory authorities, including National Agency for Food and Drug Administration and Control and other relevant agencies.
Ensure timely registration, renewal and maintenance of product licenses, permits and certifications.
Monitor and interpret changes in pharmaceutical regulations, guidelines, standards and ensure company compliance.
Serve as the primary liaison between the company and regulatory authorities on regulatory matters.
Coordinate and support regulatory inspections, audits and assessments, ensuring timely closure of observations and corrective actions.
Review product labels, packaging materials, promotional materials and artwork to ensure regulatory compliance.
Collaborate with Quality Assurance, Production, Research & Development, Pharmacovigilance and Supply Chain teams to ensure regulatory requirements are met throughout the product lifecycle.
Maintain accurate and up-to-date regulatory documentation, databases and records for all registered products.
Evaluate and approve regulatory aspects of product changes, variations and post-approval commitments.
Provide regulatory guidance and training to internal stakeholders on applicable regulations and compliance requirements.
Monitor product registration timelines and ensure timely submission of required documentation to avoid regulatory delays.
Review technical documents, product specifications, manufacturing information, and quality data for regulatory submissions.
Ensure compliance with local and international pharmaceutical regulations, guidelines and Good Manufacturing Practices (GMP).
Educational Requirement:
Bachelor's in Pharmacy
Other Requirements:
Minimum of 3 - 5 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.
Strong knowledge of pharmaceutical regulations, registration requirements and guidelines, including NAFDAC regulations, GMP and other applicable international standards.
Proven experience in preparing and managing regulatory submissions, product registrations, renewals and variations.
Thorough understanding of pharmaceutical product lifecycle management and regulatory compliance requirements.
Strong attention to detail with the ability to review technical and regulatory documents accurately.
Ability to work collaboratively with Quality Assurance, Production, Research & Development, Pharmacovigilance and Supply Chain teams.
Strong report writing, presentation and documentation skills