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Regulatory Affairs Publishing Associate Prescription - Midrand

Regulatory Affairs Publishing Associate Prescription - Midrand

Adcock IngramMidrand, Gauteng, South Africa
12 hours ago
Job description

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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    Prescription Midrand • Midrand, Gauteng, South Africa

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