• Manage internal product queries from relevant departments and external product queries from regulatory authorities and third-party stakeholders.
• Establish regulatory priorities, allocate resources, and workload, and review regulatory agency submissions to ensure compliance with standards.
• Coordinate and submit new product applications in South Africa and other territories, developing regulatory strategies and implementation plans.
• Conduct dossier due diligence to address data gaps, prepare registration applications, and work with stakeholders to assess regulators' submission requirements.

Requirements

• Bachelor's degree in Pharmacy and Diploma in Pharmacy, registered with the South African Pharmacy Council.
• Minimum 5 years of experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices.
• Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
• Sound project management capabilities and ability to consistently deliver to quality, time, and cost standards.

What We Offer

• A dynamic and supportive work environment.
• Opportunities for growth and professional development.
• Competitive salary and benefits package.

Please note that this is a general job description, and not specific to any particular location or company budget. We encourage applicants to apply who meet the minimum qualifications and requirements.