Regulatory Affairs Scientist at Pharma Dynamics (Pty) Ltd

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.

Requirements

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.