Our client in Pharmaceutical Industry, requires an experienced Regulatory Affairs Manager responsible to manage regulatory matters in South Africa. The ideal candidate has expertise in management of regulatory affairs, pharmacovigilance and quality systems.Non-Negotiable Responsible for Regulatory Affairs functions across the board Experience gained in liaising directly with Health Authorities with regards to clinical trial applications, new marketing authorization applications and lifecycle maintenance - examples to be provided. Expertise regarding pharmacovigilance, quality systems in pharmaceutical industry or Biotechnology sector Create and cultivate alignment on new regulatory pathways for current and new product development in South Africa Provide support and run regulatory affairs contribution to the product launch activities when and as needed.
Responsibilities + Skills
Ensure good relations with the Regulatory Authorities and build upon network of regulatory contacts Perform required registration processes Responsible for eCTD compilation,
Review, maintain, update, compile and submit dossiers for current and new products in South Africa Ensure guidelines and regulations compliance is adhered Ensure to update and advise department and stakeholders on regulatory matters