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REGULATORY AFFAIRS PHARMACIST - 314342
REGULATORY AFFAIRS PHARMACIST
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
Cape Town, Western Cape
Regulatory Affairs Pharmacist
Support the Regulatory Affairs function in its Lifecycle Management activities by assisting in data collection, screening, collating and compiling of the dossier / post-registration applications and wherever applicable any other documentation in order to submit the amendments to the Health Authorities for approval as per the overall objectives of Regulatory Affairs function.
Major Activities / Tasks
Perform the dossier life cycle management activities by supporting the post registration amendments and other activities in order to ensure support to the regulatory function and its objectives
Receive, prepare and submit all applicable updates, amendments, resolutions and any other correspondence required by the MCC or any other applicable regulatory authority in order to ensure timely delivery and as per the defined standards
Deliver on all post registration amendments within the defined timelines
Complete dossier audits of Registered Products
Conduct dossier due-diligences, post-registration amendments, pharmaceutical and analytical resolutions and clinical resolutions for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and in accordance with specified timelines in order to support the business and strategic company objectives
Conduct any applicable telephonic communication with MCC or any other regulatory authority as part of follow up on a timely basis
Deliver on CTD conversions by completing the same within the prescribed timelines
Preparing post-registration updates to package inserts and patient information leaflets.
Implementing any changes in regulations and advising the applicable business units.
Perform administration duties like document maintenance in order to ensure smooth operations and maintain quality standards
Ensure that the Document Database is kept in good order by completing the required administration activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
Ensure that photocopying, binding and final preparation of documents for submission to MCC and in-house copies, or any other applicable regulatory functions are completed and quality checked before final submission
Support artwork generation process by ensuring delivery of approved master label copy within the agreed timelines and approving final artwork
Develop and manage stakeholder relationship by communicating and interacting with them as needed, in order to achieve the functional objectives
Build and proactively maintain critical relationships with the MCC and equivalent bodies in other countries (as applicable), in order to ensure streamlined post-launch submissions and amendments
Manage relationships with the MCC’s units to ensure more effective streamlining of the company’s applications when required
Minimum 1 - 3 years of experience in the regulatory function covering all areas
Analytical, Attention to detail, Resilience, Collaborative approach will help perform this role effectively.