Candidate Requirements

Qualifications/Experience

Bachelor’s 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 standard

 
Key Job Outputs

Manage work streams for- and report on the assigned group of portfolios
Assisting with internal product queries from relevant departments
Assisting with external product queries from the company, 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.
Manage 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 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 value