Regulatory Affairs Pharmacist

Pharma Dynamics (Pty) Ltd.; Cape Town; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading pharmaceutical company in Cape Town is seeking a candidate to manage product and dossier life cycles, interact with regulatory bodies, and assist in compliance activities. Key responsibilities include ensuring timely submissions to SAHPRA and maintaining regulatory documentation. Ideal candidates should have relevant experience in regulatory processes and an ability to work with diverse stakeholders.

Qualifications

• Experience in product/dossier life cycle management.
• Knowledge of regulatory requirements and guidelines, particularly SAHPRA.
• Ability to liaise with various stakeholders, including regulatory bodies.

Responsibilities

• Conduct due diligence on change controls, variation packages, and dossiers.
• Compile and submit responses to regulatory updates within deadlines.
• Review and sign off submissions compiled by Regulatory Scientists.
• Maintain updates on registered products per guidelines.
• Manage the Change Control Process effectively.

Job description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW Product / dossier life cycle management Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of products within the registered SAHPRA portfolio.

Compile and submit responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.

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.

Assist in review and sign off of submissions compiled by Regulatory Scientists.

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.

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 components, 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.

Assist 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.

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.

Perform any other duties as requested.