Regulatory Compliance Specialist

2 months ago


Midrand, Gauteng, South Africa Professional Resources Partners Pty Ltd Full time
{"Regulatory Responsibilities": "

As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements in designated countries. This includes the preparation and submission of high-quality dossiers, review and approval of product labeling and promotional materials, and management of local pharmacovigilance activities.

", "Quality Assurance": "

You will be responsible for quality oversight of activities in a defined scope, including manufacturing, warehousing, and distribution. This includes QC checks and release of locally manufactured and imported products, quality documentation, self-inspections, and external audits.

", "Requirements": "

To be successful in this role, you will need to have a strong background in pharmacy, with a degree and registration with the South African Pharmacy Council. You will also need to have a minimum of 2 years' experience in quality assurance management and as a responsible pharmacist, as well as experience in compilation and submission of Act 101 and Act 36 dossiers.

", "Key Accountabilities": "

As a regulatory specialist, you will be responsible for executing regulatory strategy, agency contact, preparation and submission of dossiers, maintenance and lifecycle management of product dossiers, project management, and regulatory due diligence on potential opportunities.

", "Additional Skills": "

A strong understanding of GDP, GMP, and GWP is essential, as well as intermediate to advanced skills in MS Word, Excel, and PowerPoint. You will also need to have high accuracy and attention to detail skills, as well as a strong work ethic.

", "Preferred Qualifications": "

A GDP/GMP/GWP training or certificate would be beneficial, as would experience in the animal health industry, knowledge of regulatory submissions in Botswana, Namibia, Zambia, and Zimbabwe, and pharmaceutical production knowledge.

", "Company Overview": "

Professional Resources Partners Pty Ltd is a leading provider of recruitment services, and we are committed to finding the best talent for our clients.

", "Contact Information": "

Please do not contact us with unsolicited applications. We look forward to reviewing your application.

", "Language": "en-US"}

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