Regulatory Affairs Pharmacist - Johannesburg

 

Recruiter:

Kumusa Consulting

Job Ref:

RA-01

Date posted:

Tuesday, February 22, 2022

Location:

Johannesburg, South Africa

Salary:

R 400 000 - 600 000 Per Annum


SUMMARY:
Big Pharmaceutical Company Based in Johannesburg Has An Opportunity For A RA Pharmacist.

JOB DESCRIPTION:

  • Prepares information needed for Quality Management System’s review meeting by trending regulatory information as per set objectives per department.
  • Implements identified actions and regulatory request as per senior management’s evaluation of risk.
  • Conducts impact assessments on new/updated formulas.
  • Reports monthly on regulatory updates to Quality Assurance Manager and provides progress reports when requested.
  • Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
  • Manages the External supplier audit schedule and ensure that audits are conducted as per the schedule.
  • Conducts Internal and Supplier Audits as per the relevant Audit Schedule and follows up on all non-conformances identified.
  • Governs the External provider approval and monitoring process.
  • Ensures that findings are resolved by communicating with relevant external providers.

 

Requirements

  • Bachelor of Pharmacy or BSc Degree or Diploma in Pharmacy
  • SAPC registration will be an advantage
  • Minimum 3 – 5 years’ experience in regulatory affairs
  • In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining pharmaceutical industry
  • Knowledge of FDA, EMA, WHO and local country regulations would be advantageous

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.



 

 

 

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