Regulatory Affairs Compliance and Artwork Manager

Regulatory Affairs Compliance and Artwork Manager
Location: JHB
Equity Requirement: AA/EE
Provides support for control improvements and remediation activities including standardisation, new processes, systems and new organisational constructs. Drafts reports and recommendations for internal control deficiencies resolution or improvements to facilitate sharing of best practices related to key controls for assigned processes. Provides policy and procedure guidance.  
Key Responsibilities:
  • Ensure that all promotional material and packaging is legally compliant with the relevant statutory laws, regulations, rules and standards.
  • Approving all artwork pieces in compliance with specified guidelines (requires a sound knowledge in both the English & Afrikaans languages). SAHPRA Regulations Act 101 of 1965; Foodstuff, Cosmetics and Disinfectants Act 54 of 1972, and Trade and Metrology Act.
  • Ensure corrective action for meetings, events and other activities in line with the applicable regulatory framework.
  • Ensure that all samples requested are appropriately approved and documented according to the regulatory framework.
  • Review and approve SOPs for the Compliance department, as well as establish the need for additional controls or processes for effective quality control.
  • Provide training of all relevant staff on the Marketing Code of practice, as well as ensuring MCA certification is obtained.
Key Requirements:
  • Bachelor of Pharmacy with registration with the South African Pharmacy Council  
  • Prior experience in the pharmaceutical industry in the Regulatory or related environment
  • At least two years working experience in the field of artwork and promotional material
(Full role profile available on application)
Apply to Subject: MP/RAM
Supporting documentation required:
  • Comprehensive CV
  • Copy of Matric Certificate
  • Copy of Degree
  • Copy of Industry Body Registration