Regulatory Affairs Pharmacist

2 weeks ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Title: Regulatory Affairs Pharmacist

Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our organization, you will be responsible for managing work streams, establishing regulatory priorities, and ensuring compliance with regulatory standards.

Key Responsibilities:

  • Manage work streams for internal and external product queries
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submissions to ensure accuracy and compliance
  • Develop regulatory strategies and implementation plans for new product applications
  • Conduct dossier due diligence and prepare registration applications for submission
  • Collaborate with internal and external stakeholders to assess regulator's submission requirements
  • Maintain databases, trackers, and systems for regulatory-related activities
  • Ensure Good Regulatory Practices and compliance with Quality Management System

Requirements:

  • Bachelor's Degree in Pharmacy and registration with the South African Pharmacy Council
  • 5+ years of experience in Regulatory Affairs, preferably in human medicines
  • Proven experience in product development, commercialization, and maintenance lifecycle
  • Sound project management capabilities and ability to prioritize tasks
  • Excellent communication and collaboration skills

Preferred Qualifications:

  • Experience in use of CTD software builder and compilation of eCTD dossier applications
  • IT skills including Microsoft Office
  • Ability to work to tight deadlines and manage multiple tasks


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