Requirements:
- Grade 12
- BPharm degree
- Registered with the SAPC
- 4 to 5 years regulatory experience in the pharmaceutical industry, preferably in a development environment
- Experience in staff management
- Project management experience will be an advantage
- Working knowledge of the following:
* Regulatory requirements of the MCC, ICH, WHO, LATRAM, FDA, MHRA, CPMP, TGA and product development
- Willing to work overtime when needed

Responsibilities:
- Determine regulatory requirements and provide expert regulatory intelligence to the GPU development and technical transfer teams
- Ensure that data and documentation is generated in accordance with the market guidelines, to meet local and international regulatory
standards
- Liaise with various departments to ensure regulatory requirements of target markets are integrate into GPU projects
- Assess diverse regulatory input from international territories and consultants, to integrate such requirements into the technical matrix
- Ensure that technical data packs are compiled and contain all required data with relevant justifications and expert reports which are then
submitted to the departments as per the project plan
- Ensure that Regulatory Authority resolutions are responded to adequately and timeously
- Ensure departmental SOP's are in place and updated regularly
- Ensure that staff are trained on and adhere to all SOP's