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Regulatory Affairs Expert for Pain Management

1 week ago

Pretoria, Gauteng, South Africa Ananzi Full time

Job Summary:

This Senior Regulatory Affairs Pharmacist role involves managing work streams, reporting on product portfolios, and addressing internal and external queries.

Main Responsibilities:

  1. Manage assigned product portfolios and report on progress.
  2. Handle internal product queries from relevant departments.
  3. Address external product queries from regulatory agencies and stakeholders.
  4. Establish regulatory priorities and allocate resources.
  5. Review submissions to ensure accuracy, comprehensiveness, and compliance.
  6. Coordinate new product applications in South Africa and other territories.
  7. Develop regulatory strategies and implementation plans.
  8. Conduct dossier due diligence to address data gaps.
  9. Prepare registration applications for submission.
  10. Collaborate with stakeholders to assess submission requirements.
  11. Maintain and update existing registrations.
  12. Update databases, trackers, and systems for regulatory activities.
  13. Comply with quality management system requirements.
  14. Maintain current knowledge of relevant legislation and guidelines.
  15. Provide training and mentoring as required.
  16. Establish relationships with regulatory authorities and stakeholders.
  17. Formulate or implement regulatory affairs systems and policies.
  18. Support internal audits or regulatory inspections.
  19. Align personal and company values.