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Regulatory Affairs Director

2 months ago

Midrand, Gauteng, South Africa The Globevest Group Full time
Job Title: Regulatory Affairs Manager

Job Type: Permanent

Industry: Pharmaceutical

Location: Midrand

Job Description:

Key Responsibilities:
  • Lead Regulatory Affairs: Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.
  • Product Registration: Oversee the registration process for new products, ensuring all necessary documentation is submitted to regulatory authorities.
  • Pharmacovigilance: Manage pharmacovigilance activities, including adverse event reporting and safety updates.
  • Regulatory Documentation: Ensure all regulatory documentation meets relevant requirements and specifications.
  • Compliance: Maintain compliance with industry standards and regulations, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Quality Management: Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Training and Development: Provide training to staff on regulatory requirements, quality standards, and best practices.
Requirements:
  • Education: Bachelor's degree in Pharmacy or related field.
  • Registration: Registration with the South African Pharmacy Council (SAPC).
  • Experience: Minimum 10 years of experience in regulatory affairs, with a focus on human medicine and biologicals.
  • Skills: Strong knowledge of regulatory requirements, pharmacovigilance, and quality management systems.