Regulatory Executive at Ascentech Services Limited

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
2 years ago

Additional Details

Job ID
78347
Job Views
117

Job Description

  • Application Deadline: Tue, 12 Mar 2024 00:00:00 GMT
  • Position: Regulatory Executive

  • Job Type Full Time

  • Qualification BA/BSc/HND

  • Experience 3 - 4 years

  • Location Lagos

  • Job Field Law / Legal 



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


Requirements



  • Interested candidates should possess an HND or Bachelor's Degree with 3-4 years experience.

  • Good Interpersonal relationship

  • Team player

  • Computer literacy; ability to use Microsoft words is critical

  • Good communication skill

  • Target Orientation

  • Leadership skills.


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