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South Africa

Regulatory Affairs Pharmacist

Company Pharma Dynamics
Reference # RAP1121
Published 12/11/2021
Contract Type Permanent
Salary Market Related
Location Westlake, Western Cape, South Africa
Introduction
We seek to employ an RA Pharmacist who will manage the registration process for allocated therapeutic categories for new and existing products, including liaison with the relevant Health Authorities and third parties
Job Functions Risk Management,Science
Industries Pharmaceutical / Medical / Healthcare / Hygiene
Specification
ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product registration
•Liaise with SAHPRA Regulatory Authorities on behalf of Pharma Dynamics on new and existing queries as and when required
•Compile, sign and submit all dossier amendments as required
•Identify and maintain updates on existing products based on SAHPRA guidelines and allocated priorities
•Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities
•Compile and submit all SAHPRA recommendations, Safety Updates and amendments within agreed and specified time limits
•General management of dossiers and printed packaging components in South Africa
•Supervise/manage/coach staff complement and related activities, if/when necessary

Technical /Compliance activities
•Assist with technical queries internally and with the guidance of line management, externally
•Assist with answering relevant Pharmacovigilance and Technical queries
•Assists with review and approval of batch release documents as and when required
•Assists with periodic internal audits
•Manage and monitor the Change Control Process effectively
•Liaise with SAHPRA on registration status and technical queries




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.

General
•Perform any other duties as per changes in operational requirements of the department.
•Perform any other duties as requested
Requirements
PRE-REQUISITES
•B. Pharm registered with the SA Pharmacy Council
•Minimum of 3 years Regulatory hands-on experience
•Able to perform all standard registration processes under specialist guidance


The company reserves the right to adjust or modify the scope and / or level of the job based on applicant supply, operational requirements and/or prevailing market conditions
Job Closing Date 25/11/2021
   
   
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Last Updated: 30-6-2021 [21.06.02.21]
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