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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