Pharmacist Regulatory Affairs

Qualifications/experience
• Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
• 3 to 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

Key Job Outputs
• Manage work streams for- and report on the assigned portfolio of products:
• Assisting with internal product queries from relevant departments
• Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
• Establish regulatory priorities and allocate resources and workloads
• Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
• Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
• Develop regulatory strategies and implementation plans for the preparation and submission of new products
• Conduct dossier due diligence to ensure all data gaps are addressed
• Prepare the registration applications for submission to the regulatory authorities
• Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
• Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Internal training and mentoring
• Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
• Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Support activities such as internal audits or regulatory agency inspections
• Ensure alignment of personal and company values
• Core competencies
• Experience in use of CTD software builder and compilation of eCTD applications.

Salary R62 000 - R67 000