Permanent - Junior Regulatory Affairs Pharmacist - Johannesburg (Incl. Northern Suburbs) - South Africa

Reporting To Regulatory Affairs Manager / Senior RA Pharmacist

Job Purpose

• Entry Level position to Support the Regulatory Affairs team with the electronic compilation, documentation control and publishing of dossiers whilst tracking the relevant Regulatory milestones.
• Ensure compliant and timeous processing of regulatory submissions and prioritise commitments as assigned.
• To ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable), including the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC)

Key Job Outputs

• To Support the Regulatory Affairs team with the electronic compilation, documentation control and publishing of dossiers
• To keep track of and record Regulatory Activity
• Assisting with internal product queries from relevant cross-functional departments
• Effectively managing activity within Regulatory, QA and Administrative systems
• Adhering to Standard Operating Procedures and Regulatory Guidelines.
• Undertake internal training for self and others

Required Learning 

• Bachelor of Pharmacy
• Minimum 1 years’ experience in an Industrial or Applicant Pharmaceutical Environment (RA/QA/QC/GxP)
• Computer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems.

Core Competencies

• Attention to detail
• IT and document management savvy
• Project management ability
• Good communication and language proficiency
• Capability to prioritise and work to tight deadlines
• Systematic approach to any task execution
• Cross Functional collaboration: Ability to network, liaise and negotiate with others within the Company and also externally
• Capacity to set individual performance objectives and to monitor progress at regular intervals
• Problem solving and decision-making expertise