Regulatory Compliance Specialist
2 months ago
The successful candidate will be responsible for ensuring regulatory compliance with Act 101 and Act 53.
- Act as Responsible Pharmacist for the entity.
- Develop and implement regulatory strategies and plans.
- Prepare and submit dossiers for regulatory approval.
- Manage quality and compliance with a focus on quality management system and strategy.
- Perform audits and inspections to ensure regulatory compliance.
- Identify and implement corrective actions to address deviations and non-conformances.
- Manage Pharmacovigilance and product life cycle.
- Develop and maintain knowledge and intelligence management systems.
Requirements:
- Must have a B. Pharm degree and be registered with the South African Pharmacy Council.
- At least 2-3 years of regulatory experience.
- Experience in compilation and submission of Act 101 (SAHPRA) Dossiers and Act 36 Dossiers.
- Thorough understanding of GMP and regulatory compliance.
- High accuracy and attention to detail skills.
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