Regulatory Affairs Scientist
[Apply Now]Date Published : 07 Sep 2018 | Category: Regulatory Affairs | Expiry Date: 14 Sep 2018 | Location: Johannesburg - Aeroton | Reporting to: Head of Regulatory Affairs
Required Learning:
- Science Degree
- At least 1 year experience in Pharmaceutical Regulatory environment
- At least 1 year experience in the review and approval of marketing promotional material.
- Knowledge of regulations in all African countries as well as knowledge of the current South African regulations for medical devices
- Computer literate with prior experience with MS Office and Docubridge (Preferred)
Key Outputs :
- Co-ordination and submission of new product applications for both medical devices and medicines in the Sub-Saharan region.
- Co-ordination and submission of amendments for currently marketed products
- Co - ordinate internal processes with Marketing, Sales and Supply Chain
- Approval of marketing promotional material
- Revie and approval of packaging material
- Internal training
- Assisting with internal product queries from relevant departments
- Assisting with the design and implementation of the document management system
- Supervise the acquisition of samples
- Examine all marketing promotional material to ensure that it is legally compliant with the relevant statutory laws, regulations, rules and standards
Core Competencies:
- Knowledge of the Regulatory requirements in South Africa and Sub-Saharan region
- Leadership skills
- Ability to prioritise and work to tight deadlines
- Systems approach
- Cross Functional skills: Ability to network, liaise and negotiate with others
- Ability to set standard and objectives and monitor progress
- Problem solving and decision making skills
[Apply Now]