Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)
Description
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 Senior Regulatory Affairs Associate to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.
As the Senior Regulatory Affairs Associate you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological and vaccines products.
Primary Tasks & Responsibilities:
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Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
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Assess change controls and provide regulatory assessments of quality changes in production and quality control.
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Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
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Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
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Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
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Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
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Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Experience and Knowledge Requirements
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University-level education, preferably in Life Sciences, or equivalent by experience.
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Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
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Strong understanding of CMC and post-approval regulatory requirements.
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Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
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Knowledge of biological or vaccines processes.
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Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
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Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
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Team spirit, flexibility, accountability, and organizational skills.
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Fluent in English (written and spoken).