Regulatory Affairs Publishing Associate Prescription - Midrand

In brief

Here is the rewritten job description according to your strict rules and mandatory format: **Overview** This role as a Regulatory Affairs Publishing Associate Prescription at Adcock Ingram in Midrand involves assisting with all systems activities related to the growth and maintenance of the Regulatory Affairs Portfolio. The purpose is to identify opportunities for improving efficiency within electronic management systems, provide knowledgeable support to Regulatory Affairs Portfolio Leads for electronic databases and hard copy intellectual property, and ensure compliance with relevant Regulatory Authorities’ guidelines and the Medicines and Related Substances Control Act. This includes the timeous processing of electronic regulatory applications and life-cycle management of electronic dossiers and information. **What you will do** The individual in this role will be responsible for a range of tasks including: * Assisting with all systems activities related to the effective growth and maintenance of the Regulatory Affairs Portfolio. * Identifying opportunities within current and proposed electronic management systems for improving the efficiency of Regulatory Affairs operations. * Providing knowledgeable and controlled support to the Regulatory Affairs Portfolio Leads in maintaining electronic databases and hard copy intellectual property. * Ensuring compliance with relevant Regulatory Authorities’ guidelines (country-specific where applicable) and the Medicines and Related Substances Control Act. * Ensuring timeous processing of electronic regulatory applications and life-cycle management of electronic dossiers and information. * Coordinating work streams for assigned tasks. * Supporting the compilation and submission/filing of regulatory applications as per the latest SAHPRA & International Drug Regulatory Authority guidelines. * Supporting the compilation of eCTD responses to regulatory authority committee recommendations (clinical, pharmaceutical, and naming) timeously and in accordance with guidelines. * Ensuring that agreed timelines for approval are continuously met. * Ensuring appropriate electronic systems status updates of applications are up-to-date to maintain the status of electronic finished pharmaceutical product dossiers (eCTD). * Coordinating publishing tasks across projects, including peer review of applications generated by publishers (e.g., Relicare team). * Supporting the Regulatory Affairs Manager, Regulatory Affairs Portfolio Lead/s, and/or external Regulatory Affairs consultants in the planning, development, and publishing of applications. * Supporting various internal functional groups to ensure the compliant use of eCTD authoring guidelines, style, and conventions, and familiarity with formatting regulatory application documents to meet external and internal company submission/application ready standards. * Performing document management tasks including file transfer, storage, tracking, and archival of Regulatory Affairs application documentation. * Assisting Regulatory Affairs department members with interpreting SAHPRA, EMA, and ICH guidance as it relates to established eCTD templates, in addition to numerous other submission/filing/application types. * Maintaining working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by Health Authorities, ICH, and internal working practices. * Managing both report level publishing and submission/application-level compilation for new applications and lifecycle submissions/applications. * Participating in Regulatory initiatives aimed at improving internal regulatory standards, systems, and procedures. * Adhering to and participating in the implementation of the department’s SOPs, Regulatory Guidelines, and Checklists. * Ensuring alignment of personal and company values. * Creating and submitting Departmental Purchase Orders, including other administrative tasks as required. * Training colleagues and project teams as/when required in relation to the electronic system used. **Requirements (from the original advert)** * Grade 12 with at least 3 to 5 years’ Regulatory Affairs Operations or similar experience in the Pharmaceutical Industry, or Life Science or IT related qualification with at least 2 to 3 years’ Regulatory Affairs Operations or similar experience in the Pharmaceutical Industry. * Strong proficiency with MS-Office Suite incl. PowerBI. * Understanding of eCTD and regulatory submission requirements. * Experience with eCTD software builder applications; preferably docuBridge. * Sound project management capabilities. * Understanding of statutory requirements which will enable auditing of files. **Who should apply** The ideal candidate for this position will have a Grade 12 qualification with 3 to 5 years of Regulatory Affairs Operations or similar experience in the Pharmaceutical Industry, or a Life Science or IT related qualification with 2 to 3 years of similar experience. They should possess strong proficiency in MS-Office Suite, including PowerBI, and have a solid understanding of eCTD and regulatory submission requirements. Experience with eCTD software builder applications, preferably docuBridge, is essential, alongside sound project management capabilities and an understanding of statutory requirements for auditing files. Beyond technical skills, the successful applicant will be detail-oriented, possess excellent oral and written communication skills, and demonstrate strong relationship development skills to interact effectively with vendors and stakeholders. They should be driven, a team player who prioritizes collective success, adaptable to change, and skilled in planning, organizing, and problem-solving. A strategic thinking mindset, considering potential future consequences of actions within electronic systems, is also highly valued. **Deadline** 14 October 2026 **Reference** Original posting: https://www.myjobmag.co.za/job/regulatory-affairs-publishing-associate-prescription-midrand-adcock-ingram-1 Source: myjobmag

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• Power BI
• Project management

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