A position exists for a reliable and efficient Regulatory Affairs Pharmacist in the Pinetown area. that puts current regulatory and compliance knowledge of the plasma fractionation industry and plasma derived medicinal products to work in attaining the business goals of the company in the manufacture and sale of safe, quality, efficacious products in accordance with registration commitments, operational requirements and internationally accepted regulatory standards and those accepted by the SAHPRA.
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.
Providing pharmaceutical information and assistance required to comply with ad hoc or product specific regulatory requirements, which may be requested from time to time.
Supporting pharmaceutical, analytical or clinical compilations for miscellaneous requests to SAHPRA, such as exemptions, Section 21 applications etc.
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.
Evaluating, reviewing and compiling of additional or supportive documentation, as requested by the international regulators.
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 the company.
Identifying practices which would impact on our licensing conditions and initiate discussions and recommendations with manager for responses or initiating corrective action.
Regulatory Affairs Administration
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.
Routinely updating and archiving the electronic filing system of all regulatory guidance documents from various authorities.
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)
? Regulatory experience and skills in the compilation, preparation, submission and maintenance of dossiers and new drug applications.
? International regulatory submissions
? Experience in biologicals medicines manufacturing industry.
? e-CTD submissions
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