Regulatory Affairs Pharmacist-Johannesburg (Incl. Northern Suburbs):

Reporting To Regulatory Affairs Manager / Senior RA Pharmacist

Job Purpose

• To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers and tracking Regulatory Activity.
• Ensure compliant and timeous processing of regulatory submissions and 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 South African Pharmacy Council (SAPC)

Key Job Outputs

• Entry Level position to Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers
• Tracking Regulatory Activity
• Internal training
• Assisting with internal product queries from relevant departments
• Effectively managing activity within Regulatory, QA and administrative systems
• Preparing, reviewing and adhering to Standard Operating Procedures and Regulatory Guidelines.

Required Learning

• Bachelor of Pharmacy
• Minimum 1 year Regulatory Affairs experience but significant QA experience in pharma environment
• Computer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems

Core Competencies

• Attention to detail
• IT skills, document management skills
• Project management skills
• Good language skills
• Ability to prioritize and work to tight deadlines
• Systems approach
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standard and objectives and monitor progress
• Problem solving and decision-making skills