Regulatory Executive (Full time)

   Lagos ,

   11 months ago

Job Summary

A Regulatory Executive will be responsible for ensuring that the company complies with all relevant laws, regulations, and guidelines in their industry. He/she will work closely with government agencies and regulatory bodies to understand and interpret regulations, and then develop and implement strategies to ensure compliance. 

Job duties and responsibilities
  • Regulatory Affairs:

    • Support Superintendent Pharmacist 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

    Accountabilities

    • 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.

    Internal Contact:

    • Superintendent Pharmacist
    • Quality Assurance Manager
    • Regulatory Staff
    • All heads of Department

    External Contact:

    • NAFDAC
    • PCN
    • SON

    Measures of Performance:

    • Ongoing compliance with applicable regulatory requirements
    • Prompt registration of products
    • Accuracy of documentation output
Job requirements and qualifications
    • Interested candidates should possess an HND or Bachelor's Degree with 5 years experience.
    • Good Interpersonal relationship
    • Good communication skill
    • Target Orientation
    • Team player
    • Computer literacy; ability to use Microsoft words is critical
    • Leadership skills
Salary
  • N400,000 - N500,000
Minimum Experience
  • 2 years
Maximum Experience
  • 5 years
Application Deadline: 30th November, 2024


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