Job Description
- Job Type: Full Time
- Qualification: BA/BSc/HND, MBA/MSc/MA
- Experience: 2 – 5 years
- Location: Lagos
- Job Field: Pharmaceutical
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 the 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 the 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 the Superintended Pharmacist and QA Manager.
Compliance:
- Support and perform compliance assessments.
- Implement a compliance program.
Qualifications required:
- Degree in Pharmacy (B. Pharm/B.Sc.). M. Pharm is a plus.
- Must have a current practice license as a pharmacist.
- Overall experience of 2 – 5 years in the pharmaceutical industry as a regulatory executive.