Job Function:

• The Regulatory Affairs Executive will be responsible for all external and internal regulatory compliance for the business.

Key performance areas:

• Support the regulatory head to monitor Annual Registration of Up-country depot locations.
• CTD (Common Technical Document) evaluation and follow-up with the principal.
• Support in the registration of new products marketed and distributed by the company with NAFDAC.
• Monitoring and Managing of Pharmaco-vigilance and adverse events monitoring.
• Liaison with regulatory agencies for proper Licensing and approval required for ethical operations of pharmaceutical services.

Quality Assurance:

• Serve as Technical Officer for Diagnostic portfolio
• Support in SONCAP accreditation
• Support QA Team in achieving GDP/GWP objectives and compliance with applicable standards

Competency needed:

• Ensuring that Regulatory Objectives are achieved -70%
• On-going compliance with applicable regulatory issues to management and staff as necessary.
• Ensuring prompt communication of Quality and regulatory issues to Superintended Pharmacist and QA Manager.

Compliance:

• Support and perform compliance assessments.
• Implement compliance program.

Qualifications required:

• Degree in Pharmacy (B. Pharm/B.Sc.). M. Pharm is a plus.
• Must have current practice license as a pharmacist.
• Overall experience of 2 – 5 years in the pharmaceutical industry as a regulatory executive.