Regulatory Affairs Executive

1 month ago


Lagos, Nigeria DP World Full time

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.

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