Key Performance Areas:
- Initiate and manage the registration process for new product submissions and maintenance of existing registrations in relevant markets
- Pro-actively manage regulatory processes of key products (new products, line Extensions and actively promoted products)
- Effectively manage allocated artwork projects in the Global Labelling system.
- Consolidate and strengthen Regulatory leadership role and market access priorities
- Effectively managing, auditing and implementation of Regulatory and QA systems
- Maintain a high level of Regulatory intelligence e.g. on existing and developing regulations and on the overall competitive landscape in region
- Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
- Prepare, review and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines
- Maintain administrative systems e.g. reports, SSA databases, policies and procedures
- Alignment of personal and company values
Minimum Requirements
- Pharm or Dip Pharm qualification – other Science based qualifications will be considered provided there is extensive regulatory experience in the Sub-Saharan Africa markets
- Minimum 5 years of regulatory experience in all aspects of dossier preparation and submission in SA (main focus) but in other SADEC countries as well
- Registration with the South African Pharmacy Council