Regulatory Affairs Publishing Associate – Prescription – Midrand
Reporting to : Regulatory Affairs Portfolio Lead
Job Purpose
- Assist with all system activities related to the growth and maintenance of the Regulatory Affairs Portfolio.
- Identify opportunities within current and proposed electronic management systems for improving efficiency of Regulatory Affairs operations.
- Provide support to Regulatory Affairs Portfolio Leads in maintaining electronic databases and hard‑copy intellectual property.
- Ensure compliance with relevant Regulatory Authorities guidelines, ensuring timely processing of electronic regulatory applications and life‑cycle management of electronic dossiers and information.
Key Job Outputs
Coordinate work streams for assigned tasks.Support eCTD compilation and filing of regulatory activities per latest SAHPRA & international DRA guidelines.Respond to regulatory authority committee recommendations timeously.Meet agreed approval timelines continuously.Maintain electronic system status updates of applications.Coordinate publishing tasks across projects, including peer review of applications generated by publishers (e.g., Relicare team).Plan, develop, and publish applications.Use eCTD authoring guidelines, style and conventions; ensure documentation meets external and internal standards.Perform document management tasks : file transfer, storage, tracking, and archival of Regulatory Affairs application documentation.Interpret SAHPRA, EMA, and ICH guidance as it relates to established eCTD templates and other submission types.Maintain knowledge of regulations and processes governing controlled documents required by Health Authorities, ICH, and internal practices.Manage both report‑level publishing and submission compilation for new applications and lifecycle submissions.Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems, and procedures.Adhere to and participate in implementation of department’s SOPs, regulatory guidelines, and checklists.Core Competencies
Attention to detail.Excellent oral and written communication skills.Relationship development skills to effectively interact with vendors and stakeholders.Drive to succeed.Teamwork : Balances team and individual responsibilities; gives and welcomes feedback; contributes to building a positive team spirit.Planning & organising : Prioritises and plans work activities; uses time efficiently; completes administrative tasks correctly and on time without compromising quality.Adaptability : Able to adapt to changes in the work environment; manages competing demands; changes approach to fit the situation.Problem solving : Identifies and resolves problems in a timely manner; gathers and analyses information skillfully.Strategic thinking : Considers potential future consequences of current actions within electronic systems.Closing Date : 23 October 2025
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