Regulatory Affairs Pharmacist
Core
Manage regulatory activities for product registrations, lifecycle management, and compliance across South Africa and Sub-Saharan African markets.
Role type
Regulatory Affairs Specialist (Pharmaceuticals)
Builds
Regulatory dossiers, product registrations, and compliance submissions for pharmaceutical products.
Domain
Pharmaceuticals / Life Sciences
Deliverable
client delivery
Required skills
Pharmaceutical regulatory affairs, product registration, dossier maintenance, regulatory intelligence, stakeholder management, project management, attention to detail
Preferred skills
Sub-Saharan African market experience, quality management systems, direct engagement with regulatory authorities
Technologies
eCTD, DocuBridge, SAHPRA Engagement Portal, FTP, Veeva Vault
Responsibilities
Manage product portfolios of registered and under-review products; Compile and submit regulatory dossiers (new registrations, variations, renewals); Liaise with regulatory authorities and respond to queries; Maintain regulatory licenses and ensure timely renewals; Create and approve product artwork and labelling; Monitor regulatory intelligence and legislative changes; Support quality audits and SOP implementation; Provide regulatory guidance and training to internal stakeholders.
