Regulatory Scientist

3 days ago

Southern Suburbs, South Africa Pharma Dynamics (Pty) Ltd. Full time

Job 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.
- Identify and maintain updates on existing products based on SAHPRA guidelines and allocated priorities.
- Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on dossier related 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 (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.

***General**
- Perform any other duties as per changes in operational requirements of the department.
- Perform any other duties as requested.
- B. Pharm or B.Sc. degree or equivalent scientific qualification.
- Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.

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