Regulatory Affairs Consultant

1 week ago

South AfricaBloemfonteinRemote, South Africa Parexel Full time R1 000 000 - R2 500 000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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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