Pharmaceutical Regulatory Specialist

1 month ago


Midrand, Gauteng, South Africa Professional Resources Partners Pty Ltd Full time
Job Title: Responsible Pharmacist

We are seeking a highly skilled and experienced Responsible Pharmacist to join our team at Professional Resources Partners Pty Ltd.

Job Summary:

The successful candidate will be responsible for ensuring the quality and regulatory compliance of our pharmaceutical products. This includes preparation and submission of dossiers, management of local pharmacovigilance activities, and quality oversight of activities in a defined scope.

Key Responsibilities:
  • Regulatory: Prepare and submit dossiers, manage local pharmacovigilance activities, and ensure regulatory compliance.
  • Quality: Oversee quality activities, conduct audits and inspections, and ensure quality documentation is up-to-date.
Requirements:
  • Matric/Grade 12
  • Pharm degree
  • Registered with The South African Pharmacy Council
  • Minimum 2 years Quality Assurance Management experience
  • Minimum 2 years' experience as a Responsible Pharmacist
  • Minimum 2 years' experience in compilation and submission of Act 101 (SAHPRA) and Act 36 (DALRRD) dossiers
  • CTD dossier format submission experience
  • Thorough understanding of GDP/GMP/GWP
  • MS Word, Excel, and PowerPoint – intermediate to advanced skills required
  • High accuracy and attention to detail skills
  • Strong work ethic
Desirable Qualifications:
  • GDP/GMP/GWP Training/Certificate
  • Animal Health industry experience
  • Knowledge of regulatory submissions in Botswana, Namibia, Zambia, and Zimbabwe
  • Pharmaceutical Production knowledge


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