Regulatory Affairs Specialist

1 week ago


Randburg, Gauteng, South Africa Staff Domain Inc. Full time
Job Title: Regulatory Affairs Coordinator

Staff Domain Inc. is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory team, you will be responsible for ensuring our products comply with global regulatory requirements.

Key Responsibilities:
  • Request and collect documents from vendors and other sources to support product compliance.
  • Collaborate with senior management and business partners to ensure regulatory compliance.
  • Support new and existing product process improvements and global market compliance.
  • Respond to internal and external document requests, tracking timing and progress with vendors.
  • Implement and maintain regulatory processes, protocols, and programs to ensure chemical-compliant and robust regulatory practices.
Requirements:
  • Minimum BA or BS degree in a relevant field, with chemical documentation and Quality Control familiarity.
  • 5-10 years of experience in the chemical or related industry, with a regulatory role.
  • Strong knowledge of cGMPs, writing internal documents, and creating basic product documents.
  • Hands-on working knowledge of FDA product requirements and experience with FDA inspection.
  • Excellent communication and collaboration skills, with the ability to articulate requirements to colleagues.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Experience with Microsoft Office, SharePoint, and Access-type systems.
Benefits:
  • HMO Coverage
  • Life Insurance
  • Provident Fund


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