About This Role<\/p>\n
\tAre you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented\u00a0Regulatory Affairs Consultant\u00a0to join our dynamic team! This role is for a client dedicated project, and the role can be home based or office based in Bloemfontein.
\n\tAs 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.<\/p>\n
Primary Tasks & Responsibilities:<\/p>\n
\tDevelop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
\n\tAssess change controls and provide regulatory assessments of quality changes in production and quality control.
\n\tReview study reports from the quality control and production departments to ensure compliance with regulatory requirements.
\n\tCoordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
\n\tWrite and\/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
\n\tManage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
\n\tIdentify, escalate, and mitigate risks associated with regulatory procedures and activities.<\/p>\n
Experience and Knowledge Requirements:<\/p>\n
\tUniversity-level education, preferably in Life Sciences, or equivalent by experience.
\n\tPrevious experience in regulatory affairs, particularly related to\u00a0technical\/CMC\/quality,\u00a0within the pharmaceutical industry.
\n\tStrong understanding of CMC and post-approval regulatory requirements.
\n\tExperience in writing CMC (technical) sections of regulatory documents such as registration files or variations – strong plus
\n\tKnowledge of vaccines and\/or biological processes.
\n\tBackground in validation\/Quality Assurance\/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of\u00a0qualification\/validation\u00a0principles.
\n\tProficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
\n\tTeam spirit, flexibility, accountability, and organizational skills.
\n\tFluent in English (written and spoken).<\/p>\n
Apply via company website ( https:\/\/www.parexel.com\/ ) or<\/p>\n
jobs.parexel.com<\/p>\n
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