Job Description

Position summary
Industry: FMCG & Supply Management
Job category: FMCG, Retail, Wholesale and Supply Chain
Location: Western Cape
Contract: Permanent
EE position: Yes
About our company
Clicks Group
Introduction
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