Regulatory Affairs Consultant

1 week ago

Bloemfontein, South Africa Parexel Full time

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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