To ensure that Consumer Healthcare (CH) complies with the laws and regulations that govern the manufacturing, registration, sales, marketing and promotion of medicines in South Africa and complies with the laws, regulations and Company standards that govern the sale and promotion of consumer products in South Africa.
The Head of Regulatory Affairs South Africa will be a member of the South Africa Leadership Team and is responsible for the development of CH sector-leading regulatory capabilities. More specifically, this role is accountable for the development of Regulatory strategies and capabilities across South Africa in order to deliver a pipeline of creative and competitive claims and products, engage appropriately in the external environment to stimulate change which is of benefit to the company’s portfolio and ensure ongoing regulatory compliance and medical governance. This will involve leading and coaching CH regulatory professionals to build the infrastructure, networks and organisational capability needed to deliver the Winning Formula. The role requires close internal linkages with Regional and LOC commercial teams, South Africa Leadership Team peers as well as within the Global Regulatory and Quality/R&D groups to embed best-practice, world class capabilities across all of these areas. In addition the role requires the development of effective, credible and transparent high quality relationships with KOLs, Government bodies, NGO’s and other stakeholders across South Africa.
Analysis of dossiers and deciding if product is a foodstuff, cosmetic, complementary medicine or orthodox medicine
Classification of denture whiteners/cleansers as cosmetics when they should actually be classified as disinfectants
New regulations and laws are published on a regular basis by the government that need analysis and clarification to the business
Prioritize between project by deciding on the impact of the projects in meeting annual business objectives
Independent Thinking:
• Application of the marketing code principles in the promotion of Consumer medicines
• Finding and suggesting alternatives to complex issues
• The position is governed by legislations, company procedures and standards to a very large degree
Responsibility:
• Strengthening of promotional claims for marketing
• Expediting registration of products to ensure the company is “first to market”
• Commenting/objecting on proposed regulations that make it difficult for the company to do business
• Ensuring that competitors are not making claims that are beyond the approved package insert
• Identifying and sourcing new products from other markets

Annual Strategic Planning:
• It is essential that the annual expenditure on product registrations is properly controlled and quantified
• Appropriate budget control for new product launches.
• Help manage environmental changes (e.g. Legislation changes) in order to plan in advance for their impact, whether positive or negative

Qualifications:
• BPharm degree
• 7-10 years’ experience in a management position within the pharmaceutical regulatory environment.
Knowledge required:
• Pharmaceutical, Cosmetics and Foodstuffs legislation
• In depth knowledge of the Trade Metrology Act and operations at the SABS
• Soft Drinks Regulations
• Working knowledge of pharmacological and pharmaceutical principles
• Registration of medicines (communication with MCC)
• Quality Assurance principles, e.g GMP, GWP, etc.)
• Industry involvement/knowledge (SMASA, SAPRAA, etc.)
• Customer Service and communication (ADRs, complaints, etc)