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Regulatory Affairs Operations Lead

Regulatory Affairs Operations Lead

Unique Personnel (Pty) LtdJohannesburg, Gauteng, South Africa
2 days ago
Job description

Regulatory Affairs Operations Lead

Posted today

Closing date : 15 October 2025

Job Purpose

The Regulatory Affairs Operations (RegOps) Lead is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre‑ and post‑approval filing and ongoing document maintenance within the OTC division. The role requires supervising the formatting, publishing, compilation and submission of all regulatory documentation to national and international authorities and leading multi‑disciplinary project teams.

Responsibilities

  • Lead and supervise the creation, assembly and publishing of electronic submissions, including New Product Applications and Life Cycle Amendments.
  • Maintain submission‑planning timelines for assigned submissions and ensure timely approvals.
  • Represent Regulatory Affairs on project teams, driving project deliverables related to electronic submissions.
  • Liaise with clinical, quality, regulatory and functional source areas to ensure documents comply with authoring style guides and regulatory requirements.
  • Support and lead the development, refinement and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities.
  • Manage and streamline document preparation and management systems, continuously improving efficiency and quality.
  • Ensure alignment of personal and company values in all regulatory activities.

Qualifications and Experience

  • Pharmacy bachelor’s degree or equivalent in life sciences or technology with a minimum of 2 years Regulatory Operations experience.
  • OR Grade 12 with at least 5 years pharmaceutical industry experience, with prior Regulatory Operations experience.
  • Demonstrated experience leading project management, timelines and collaboration across cross‑functional teams.
  • Expertise in document management, eCTD format and regulatory submission requirements and eCTD publishing systems.
  • Advanced technical skills in electronic regulatory document preparation, submission and lifecycle management systems.
  • Experience developing work instructions and SOPs consistent with health authority requirements.
  • Proven ability to manage, streamline and collaborate to improve document preparation and management systems.

    • Core Competencies

  • Advanced technical skills in electronic regulatory document preparation and submission.
  • Excellent negotiation, relationship development, and vendor management skills.
  • Strong problem‑solving, leadership, and organizational skills.
  • Excellent oral and written communication abilities.
  • Proficiency with MS‑Office Suite and Adobe Acrobat.
  • Alignment with company values, responsibility, excellence and collaboration.

    • Key Job Outputs

  • Oversee operations of teams managing creation and publication of electronic submissions.
  • Represent RA on project teams, ensuring timelines and deliverables are met.
  • Maintain knowledge of regulations and processes governing controlled documents.
  • Ensure documents comply with style guides and regulatory requirements.
  • Support and lead development of internal processes and procedures for submission production.
  • Ensure alignment of personal and company values.

    • Reporting to : Regulatory Affairs OTC

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    Regulatory • Johannesburg, Gauteng, South Africa