Regulatory Affairs Publishing Associate Prescription - Midrand at Adcock Ingram

Job Purpose 

• Assist with all systems activities related to the effective growth and maintenance of the Regulatory Affairs Portfolio.
• Identify opportunities within the current and proposed electronic management systems for improving efficiency of the Regulatory Affairs operations.
• Provide knowledgeable and controlled support to the Regulatory Affairs Portfolio Leads in terms of maintaining electronic databases, as well as hard copy intellectual property.
• Ensure compliance with the 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

Requird Learning 

• 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.

Key Job Outputs

• Coordinate work streams for the assigned tasks.
• Supporting the compilation and submission/filing of regulatory applications as per latest SAHPRA & International Drug Regulatory Authority guidelines.
• Supporting the compilation of eCTD responses to the regulatory authority committee recommendations (clinical, pharmaceutical and naming) timeously and in accordance with guidelines.
• Ensuring that the agreed timelines for approval are continuously being met.
• Ensuring appropriate electronic systems status updates of applications are up-to-date to maintain status of electronic finished pharmaceutical product dossiers (eCTD).
• Coordinate publishing tasks across projects including peer review of applications generated by publishers (e.g., Relicare team).
• Support the Regulatory Affairs Manager, Regulatory Affairs Portfolio Lead/s and/or external Regulatory Affairs consultants in the planning, development, and publishing of applications.
• Support various internal functional groups ensuring the compliant use of eCTD authoring guidelines, style and conventions. Familiarity with formatting regulatory application documents ensuring that documentation meets external and internal company submission/application ready standards.
• Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory Affairs application documentation.
• Assist the Regulatory Affairs department members with interpreting SAHPRA, EMA and ICH guidance as it relates to the established eCTD templates, in addition to numerous other submission/filing/application types.
• Maintain 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.
• Responsible for managing both report level publishing and submission/application-level compilation for new applications and lifecycle submissions/applications.
• 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.
• Ensure alignment of personal and company values.
• Departmental Purchase Order creation and submission, including other administrative tasks as required.
• Train colleagues and project teams as/when required in relation to the electronic system used.

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; Contribute to building a positive team spirit; Puts success of the team above own interests; Supports everyone’s efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
• Planning & organising: Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly, on time without compromising quality (even when under pressure).
• Adaptability: Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Problem Solving: Identifies and resolves problems in a timely manner; gathers and analyses information skillfully.
• Strategic thinking: Thinking of potential future consequences caused by current actions within the electronic systems being used.

 Closing Date : 14 October 2026

Requirements

• 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.