Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office bas
当我们的价值观一致时，我们能达到什么样的目标都没有限制。在 Parexel,我们都有相同的目标 - - 改善世界健康。从临床试验到监管，咨询和市场准入，我们提供的每一个临床开发解决方案都是基于某种特殊的东西 - - 我们对所做的事情深厚的信念。无论我们在 Parexal 做什么，我们每个人都有助于发展一种治疗最终会有益于患者。我们把工作作为个人，我们以同情感做起来，我们致力于改变。你是一个经验丰富的监管专业人士吗？你正在寻找新的机会？我们目前正在寻找一位有才华的高级监管事务副总裁，加入我们的动态团队！这是一个专为客户的项目，角色可以在欧洲各个地点设置办公室或家庭。作为高级监管部门副总裁你将在公司全球经批准后的监管活动中发挥重要作用，特别关注生物产品化学，制造和控制 (CMC).主要任务和责任：·制定提交策略和计划，以进行变化，续订，市场扩张以及年度报告等 MC 活动后的批准。·评估生产和质量控制的变化管制，并提供有关产品质量变化的监管评估。·审查对质量控制和生产部门的研究报告以确保符合监管要求。·与制造业，供应链，质量控制及质量保证等各部门协调提交准备，以及其他监管部门和当地公司进行编写和/或审查提交内容以确保与监管要求一致，特别是与卫生当局的变化和问题相关。· 管理所有监管信息管理系统内的项目，确保全球提交的文件保持。· 确定，升级和减轻与监管程序和活动相关的风险。经验和知识要求：· 大学教育，最好是生命科学或相等于经验。· 在制药行业中在监管事务上有以前的经验，特别是有关技术/CMC/质量。· 深入了解 CMC 和批准后的监管要求。· 写作监管文档中的 CMC （技术）分类的经验。
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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:
- 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.
- Knowledge of biological or vaccines 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).
Originally posted on Himalayas