SUMMARY:
Our client in the Pinetown area is recruiting for a Regulatory Affairs Pharmacist, who puts current regulatory and compliance knowledge of the plasma fractionation industry and plasma derived medicinal products.
POSITION INFO:
Updating current product dossiers in the appropriate format by reviewing, co-ordinating, and authoring of proposed pharmaceutical, analytical or clinical documentation as required to secure regulatory approval and compliance.
Sourcing and referring to current regulatory Guidelines in the analysis/or review of amendments/variations in relation to company''s current or intended practices that impact on the product registration dossiers.
Evaluating, reviewing and compiling of additional or supportive documentation, based on pharmaceutical; safety; quality and efficacy principles, as requested by the regulators.
Evaluating, reviewing and compiling of additional or supportive documentation for resolving issues identified as part of new medicine applications.
Keeping updated with international registration requirements and evaluate company compliance for pharmaceutical, analytical and clinical aspects and specific requirements.
Planning and organising the specified documentation and work flow processes such that product submissions and approvals are expedited.
Evaluating and verifying that the registration information included as part of the registration package is up to date and reflects current company and international practice.
Monitoring the SAHPRA and other international regulatory websites (EMEA, FDA, MHRA, and TGA) to keep updated with regulatory changes.
Attending and participating at various external meetings and training forums to keep abreast with regulatory changes and trends.
Evaluating and communicating regulatory requirements and standards in order to facilitate change requests and monitoring of the implementation of these changes within company.
Updating the paper and electronic databases and filing systems for regulatory submissions, applications and their supportive documentation as required.
Updating the paper and electronic databases and filing systems for promotional material and their supportive documentation as required.
Updating the paper and electronic databases and filing systems for packaging material and their supportive documentation as required.
Internal and external networking and support
Bachelor’s Degree in Pharmacy
Medicines registration and CTD/e-CTD training
2 years in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
MS Office proficiency (Word, Excel, PowerPoint, Outlook)
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