Regulatory Affairs Specialist

2 weeks ago


Midrand, Gauteng, South Africa Emporium Full time
Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)

Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our Regulatory Affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.

Key Responsibilities:

  • Manage internal and external product queries from relevant departments and regulatory authorities
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submissions to ensure timelines, accuracy, and compliance with regulatory standards
  • Coordinate and submit new product applications in South Africa and other applicable territories
  • Develop regulatory strategies and implementation plans for new products
  • Conduct dossier due diligence to ensure data gaps are addressed
  • Prepare registration applications for submission to regulatory authorities
  • Collaborate with internal and external stakeholders to assess regulator's submissions requirements
  • Maintain existing registrations and update databases, trackers, and systems
  • Comply with Quality Management System requirements and maintain Good Regulatory Practices
  • Stay up-to-date with relevant Acts, Regulations, and Guidelines
  • Internal training and mentoring of peers
  • Establish and maintain effective relationships with Regulatory Authorities and stakeholders

Requirements:

  • 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 the product development, commercialization, and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time, and cost standards
  • Good Manufacturing Practices and Pharmaceutical production experience

What We Offer:

  • Competitive salary
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment

How to Apply:

Please send your MS Word format CV to jobsemporium.co.za and use POS24325 – Snr RA Pharma in the subject line.



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