高级法规事务专员 - CMC生物制品/疫苗（居家或办公室办公）
Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office bas
当我们的价值观一致时，我们能够实现无限可能。
在Parexel，我们都有相同的目标——改善全球健康。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源于一种特殊的理念——对所做工作的深刻信念。
无论我们在Parexel做什么，都在为最终惠及患者的疗法开发做出贡献。我们认真对待工作，以同理心去完成，并致力于带来改变。
你是否是一位经验丰富的监管事务专业人士，正在寻找新的机会？我们目前正在寻找一位才华横溢的高级监管事务专员加入我们的团队！这是一个客户专属项目，该职位可在欧洲多个地点的办公室或居家办公。
作为高级监管事务专员，你将在公司全球上市后监管活动中发挥关键作用，特别专注于生物制品和疫苗产品的化学、制造和控制（CMC）方面。
主要职责与任务：
- 为上市后CMC活动的提交策略和计划进行开发，如变更、续期、市场扩展和年度报告。
- 评估变更控制并提供生产及质量控制中的质量变更的监管评估。
- 审查质量控制和生产部门的研究报告，确保符合监管要求。
- 协调与制造、供应链、质量控制和质量保证部门以及其他监管部门和当地公司的提交准备工作。
- 编写和/或审核提交内容，确保符合监管要求，特别是与变更和卫生当局的问题相关。
- 在所有监管信息管理系统中管理项目，确保全球提交的维护。
- 识别、上报并减轻与监管流程和活动相关的风险。
经验和知识要求：
- 大学学历，最好是生命科学专业，或通过经验等同于该学历。
- 在监管事务方面有经验，特别是与制药行业中的技术/CMC/质量相关。
- 对CMC和上市后监管要求有深入了解。
- 有编写监管文件中CMC（技术）部分的经验，如注册文件等。
查看英文原文
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