12 дней назад
Regulatory Affairs Pharmacist
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Affairs Pharmacist (Pharmaceutical Compliance): Managing product registrations, regulatory dossiers, lifecycle activities, and compliance initiatives across South Africa and selected Sub-Saharan African markets with an accent on eCTD submissions, regulatory authority engagement, and pharmaceutical labelling requirements. Focus on maintaining product portfolios and licenses, responding to regulatory queries, monitoring legislative changes, and supporting audits and quality systems.
Location: Johannesburg, South Africa
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Manage portfolios of registered products and products under regulatory review.
- Compile and submit dossiers for new registrations, variations, renewals, and maintenance activities.
- Support New Chemical Entity, CTD, and electronic submissions.
- Liaise with regulatory authorities, respond to queries, and maintain regulatory licenses.
- Create and approve product artwork and labelling materials while ensuring compliance with medicines, packaging, advertising, and promotion regulations.
- Monitor regulatory intelligence, support audits and SOP implementation, and provide regulatory guidance and training to internal stakeholders.
Requirements
- BPharm degree and registration with the South African Pharmacy Council.
- At least 3 years of pharmaceutical regulatory affairs experience.
- Experience with product registrations, variations, renewals, and dossier maintenance.
- Working knowledge of eCTD, DocuBridge, the SAHPRA Engagement Portal, FTP, and Veeva Vault.
- Strong understanding of pharmaceutical regulatory requirements and lifecycle management.
- Excellent communication, stakeholder management, project management, prioritisation, and attention to detail.
Nice to have
- Experience working across South Africa and other Sub-Saharan African markets.
- Knowledge of quality management systems and pharmaceutical compliance requirements.
- Experience engaging directly with regulatory authorities.
Culture & Benefits
- 12-month fixed-term contract.
- Work in a fast-paced healthcare and pharmaceutical environment.
- Collaborate with cross-functional stakeholders across regional regulatory activities.
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