Job Description

Key Job Outputs

• Manage work streams for- and report on the assigned group
• Co-ordination and submission of new product applications in South Africa and other applicable territories.
• 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.
• Manage activities such as internal audits or regulatory agency inspections
• Ensure alignment of personal and company value

• Experience in use of CTD software builder and compilation of eCTD application
• will be an advantage.
• IT skills
• Leadership skills
• management of personnel resources
• Ability to prioritise and work to tight deadlines
• Systems and operations analysis
• Basic cost management skills
• Active learning
• Strategic thinking
• Ability to cope with a high degree of complexity and change
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standards and objectives and monitor progress
• Complex problem solving and decision-making skills
• Customer relationships
• Development of people
• Must demonstrate responsibility, excellence and collaboration and align with
• Company values

• Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

• Minimum of 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

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