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.

PRE-REQUISITES

B. Pharm registered with the SA Pharmacy Council Minimum of 2 - 3 years Regulatory hands-on experience, within the pharmaceutical industry. * Able to perform all standard registration processes under specialist guidance.