Regulatory Affairs Manager

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 Core competencies 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 Qualifications Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council Experience 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