Regulatory Affairs Scientist (Southern Suburbs (Cape) at Pharma Dynamics (Pty) Ltd

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, 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.
• Perform any other duties as requested.

Requirements
PRE-REQUISITES

• B.Sc. degree or equivalent scientific qualification.
• Minimum of 1 - 2 years Regulatory experience in submitting variations to SAHPRA’s CEM, PEM and inspectorate units.
• Experience with eCTD software will be beneficial.
• Able to perform all standard registration processes under specialist guidance.