Regulatory Executive at Ascentech Services Limited

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.