Regulatory Affairs Consultant

1 week ago

Bloemfontein, Orange Free State, South Africa Parexel Full time R500 000 - R1 000 000 per year

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented
Regulatory Affairs Consultant
to join our dynamic team This role is for a client dedicated project, and the role can be home based or office based in Bloemfontein.

As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for vaccines and/or biological products.

Primary Tasks & Responsibilities

  • Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience And Knowledge Requirements

  • University-level education, preferably in Life Sciences, or equivalent by experience.
  • Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations - strong plus
  • Knowledge of vaccines and/or biological processes.
  • Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Fluent in English (written and spoken).

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