Regulatory Compliance Specialist
4 weeks ago
Unique Personnel Ltd is seeking a highly skilled Regulatory Affairs professional to support the Regulatory team in providing superior services to relevant departments within the company and external partners. Key Responsibilities:
- Manage work streams, report on assigned groups, and assist with internal and external product queries.
- Establish regulatory priorities, allocate resources, and review submissions for accuracy, comprehensiveness, and compliance.
- Coordinate and submit new product applications, develop regulatory strategies, and conduct dossier due diligence.
- Work with internal and external stakeholders to assess regulator's requirements and ensure maintenance of existing registrations.
Requirements:
- Bachelor's degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council.
- Minimum 5 years of experience in Regulatory Affairs, preferably in human medicines.
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
Unique Personnel Ltd values its employees and offers a dynamic work environment with opportunities for professional growth and development.
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