Regulatory Affairs Scientist

**KEY RESPONSIBILITIES**

**Product registration**
- Conduct due diligence on received change controls, variation packages, and dossiers pertinent to,but not restricted to, LCM of the assigned product portfolio.
- Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.
- Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.
- Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.
- Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.
- Compile and submit all responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.
- Maintain the department’s online apps (eg. CCP database, docuBridge, AW app etc) as per official SOPs and/or working instructions.
- Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Act 101 and the Marketing Code.
- Supervise/manage/coach staff complement and related activities, if/when necessary

**General**
- Perform any other duties as per changes in operational requirements of the department.
- Perform any other duties as requested.

**Technical /Compliance activities**
- Manage and monitor the Change Control Process effectively
- Liaise with SAHPRA on registration status and technical queries
- Assist with technical queries internally and with the guidance of line management, externally, as/when necessary.
- Assist with answering relevant Pharmacovigilance and Technical queries, as/when necessary.
- Assists with review and approval of batch release documents, as/when necessary.
- Assists with periodic internal audits, as/when necessary.

**Packaging material**
- Review and facilitate approval of printed packaging components
- Ensure all printed material, complies with the Marketing Code of Conduct and SAHPRA requirements

**Document management**
- Ensure the EDMS is current and up to date and in line with submitted dossiers.

**PRE-REQUISITES**
- B.Sc. degree or equivalent scientific qualification.
- Minimum of 2 - 3 years Regulatory hands-on experience, within the pharmaceutical industry.
- Able to perform all standard registration processes under specialist guidance.