Regulatory Affairs Executive
1 month ago
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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