Regulatory Affairs Consultant - CMC vaccines or biologics (home or office based)

Parexel; Bloemfontein; Hybrid; ZAR 300 000 - 400 000; Full time

Job summary

A global regulatory affairs firm is seeking an experienced Regulatory Affairs Consultant in Bloemfontein. The candidate will focus on CMC post-approval regulatory activities for vaccines and collaborate with various departments. They should have a solid background in regulatory affairs and knowledge of pharmaceutical industry standards. This role can be performed from home or on-site.

Qualifications

• University-level education, preferably in Life Sciences, or equivalent experience.
• Previous experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.

Responsibilities

• Develop submission strategies for CMC activities.
• Provide regulatory assessments of quality changes in production.
• Review study reports to ensure compliance with regulatory requirements.

Skills

Regulatory affairs experience

Knowledge of CMC

Fluent in English

Proficiency in Word, PowerPoint, Excel

Team spirit

Education

University-level education in Life Sciences

Tools

Veeva Vault

Job description

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, elevate, 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).