Regulatory Affairs Specialist

12 hours ago


Midrand, Gauteng, South Africa Emporium Full time

Emporium is seeking a skilled Regulatory Affairs Specialist to join our team in Midrand. This role offers a unique opportunity to leverage your expertise in pharmaceutical regulations and compliance.

Job Overview:

The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and allocating resources. They will also review regulatory agency submissions, coordinate new product applications, and ensure compliance with relevant legislation and guidelines.

Key Responsibilities:

  • Manage work streams for assigned portfolios of products
  • Establish regulatory priorities and allocate resources
  • Review regulatory agency submissions for timelines, accuracy, and compliance
  • Coordinate new product applications and registrations
  • Develop regulatory strategies and implementation plans
  • Conduct dossier due diligence and prepare registration applications
  • Maintain databases, trackers, and systems for regulatory activities
  • Comply with Quality Management System requirements for Good Regulatory Practices
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines
  • Support internal audits and regulatory agency inspections

Requirements:

To succeed in this role, you will need:

  • Bachelor's Degree in Pharmacy and Registration with the South African Pharmacy Council
  • 5+ years' experience in Regulatory Affairs, preferably in human medicines
  • Demonstrable experience across product development, commercialization, and maintenance lifecycle
  • Sound project management capabilities and proven ability to deliver quality, time, and cost standards
  • Good Manufacturing Practices (GMP) knowledge and pharmaceutical production experience
  • Excellent IT skills, including Microsoft Office and CTD software builder
  • Ability to prioritize and work to tight deadlines, manage complexity, and cope with change
  • Strong communication, problem-solving, and decision-making skills

What We Offer:

Emporium offers a competitive salary range of R950,000 - R1,000,000 per annum, depending on experience. If you are a motivated and experienced Regulatory Affairs professional looking to take your career to the next level, we encourage you to apply.



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