Regulatory Affairs Scientist

Pharma Dynamics (Pty) Ltd.; South Africa; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company in South Africa is seeking a Regulatory Affairs Manager to oversee regulatory activities, manage change control processes, and liaise with SAHPRA. The ideal candidate will have experience in regulatory submissions and knowledge of SAHPRA guidelines. Responsibilities include conducting due diligence on documentation, compiling responses to SAHPRA recommendations, and maintaining departmental workflows and online applications. This role offers an opportunity to work in a dynamic environment focusing on product lifecycle management.

Qualifications

• Experience with regulatory submissions and compliance processes.
• Strong understanding of SAHPRA guidelines.
• Ability to manage and monitor change control processes.

Responsibilities

• Conduct due diligence on change controls and dossiers for product registration.
• Compile and submit responses to SAHPRA recommendations.
• Liaise with SAHPRA regarding queries on products.

Job description

Overview

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, life cycle management of products within the registered SAHPRA portfolio.
• Compile and submit responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits, with a focus on allocated phased in approach on complexity of submissions
• 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.
• Assist with maintaining applicant interface of SAHPRA apps (eg. Engagement Portal, NDS), pertaining to life cycle management of products, to streamline departmental workflow.
• Maintain the department’s online apps (eg. CCP database, docuBridge etc) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalise printed packaging, as/when required.
• Supervise/manage/coach staff complement and related activities, if/when necessary.

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 in obtaining information pertaining to Pharmacovigilance and Technical queries, as/when necessary.
• Assists in obtaining information pertaining to batch release queries, as/when necessary.
• Assists with periodic internal audits, as/when necessary.

Packaging material

• Review and facilitate approval of printed packaging components as per SAHPRA requirements, on behalf of the division.

Document management

• Ensure docuBridge is current and up to date and in line with submitted dossiers.
• Ensure CCP database is aligned to regulatory updates implemented in docuBridge .

General

• Perform any other duties as per changes in operational requirements of the department.