We are looking to employ a Technologist (Africa & Distribution). To manage regulatory requirements for foreign countries i.e. Botswana, Namibia, Lesotho and eSwatini. To drive, safeguard and enhance the Clicks brand by taking responsibility for ensuring all products comply with relevant legislation and meet international quality, health and safety requirements for foreign countries. This role will be based at our Head Office in Woodstock, Cape Town and report to the Technical Manager.
Job description
Job Objectives:
To manage the preparation and compilation of documentation including the tracking, submission and filing thereof across all departments, including medical devices, complementary medicines, cosmetics and foods to comply with legislation related to foreign countries
To liaise with external and internal stakeholders to ensure that all required documentation is received and comply with the relevant requirements to report on meeting business timelines and expectations accordingly
To build complete and accurate dossiers for submission to regulatory bodies and monitor and track submissions to address queries timeously as received from regulatory bodies
To develop and implement templates and Standard Operating Procedures (SOPs) that outline the processes and tasks necessary to meet KPIs
To register products on relevant portals timeously, within budget and manage the budget accordingly
To build and maintain strategic relationships with regulatory bodies across departments within the various countries to ensure ongoing compliance and enable timely feedback to the relevant stakeholders which includes early notification of regulatory changes, efficient resolution of issues, mitigating risk and strengthening influence within regulatory frameworks
To build and implement a long-term strategy to ensure compliance with business and regulatory requirements.
To lead regulatory change within the organisation by managing the implementation of the change and facilitating the necessary training of employees to ensure total compliance within product development
To monitor market changes aligned to global regulations to determine potential impact to a product's ability to be sold in certain regions or countries
To manage the data capturing and document maintenance process on the regulatory system to ensure accurate and timeous record keeping, across all categories and departments
Minimum requirements
Job Related Knowledge
Strong knowledge of the Regulatory Landscape - Legislations, Regulations and guidelines
Understanding and implementation of cosmetic/medical devices/complementary medicines/food regulations
Understanding of labelling laws; product safety and quality processes for relevant categories.
Job Related Skills
Essential:Excellent planning and organisational skills
Ability to work on multiple projects and across teams
Attention to detail
Excellent document administration
Good verbal and written communication skills
Ability to interpret regulations, provide industry comment, implement strategies to comply and communicate risk
Ability to overcome cultural and language barriers to achieve requirements
Desirable:Computer literacy - Word, Excel Intermediate, Outlook and Power Point
Critical Path Management
Analytical and ability to solve problems
Job Experience
Essential:Minimum 3 years' experience in regulatory affairs in manufacturing/retail industry
Minimum 3 years' experience in dossier compilation
Desirable:No less than 1 years experience with any African regulatory body other than SAHPRA (e.g. experience with BOMRA, ZAMRA, NAMRA)
Education
Diploma/Degree in Biotechnology/Quality Control/Science based studies (Chemistry)/Cosmetic Science/Pharmacy/Regulatory Affairs
Competencies
Deciding and Initiating Action
Adhering to Principle and Values
Persuading and Influencing
Applying Expertise and Technology
Learning and Researching
* Planning and Organising
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