法规注册与合规经理
Manager, Regulatory Registration and Compliance
医学在这里不断前进，你也将如此。
在PrimeVigilance，患者安全不是工作的某一部分，而是我们存在的理由。
我们是一家全球药物警戒专家。我们的团队帮助客户应对复杂的法规，同时将患者安全置于每个决策的核心，从早期开发到上市后监测。越来越多地，我们创造的价值不仅在于处理安全数据，更在于解读数据：尽早发现重要的信号，并将其转化为客户可以采取行动的见解。
这项工作需要充满好奇心的头脑、解决问题的人和关心把事情做对的专家。它也需要一个值得留下的文化。在欧洲、北美、南美、亚洲和澳大利亚，我们在一个以善良、灵活性、成长和归属感为基础的环境中工作，同事之间互相支持，无论来自何处的好想法都会被听到。
如果你想要一份有真正意义、具有全球影响力，并且在帮助保护患者的同时能够持续成长的工作，你会在这里感到自在。我们期待收到你的来信。
监管注册与合规经理负责根据监管要求制定策略，并准备/审核相关的项目计划、联合操作规程和/或模板。他们积极参与业务发展经理（BDM）活动，为提案/预算做出贡献，协助高级管理层获取新业务。该职位还为初级成员提供战略监管指导、培训、辅导和指导；可能需要直接管理员工。
· 领导和协调复杂的监管项目，确保按时、高质量交付并符合监管要求。
· 制定监管策略，管理项目启动活动，并向内部和外部利益相关者提供专业指导。
· 准备、审核并监督向FDA、EMA和其他卫生当局的监管提交和文件。
· 识别和缓解风险，解决项目问题，并确保遵守公司流程和标准。
· 管理项目资源、预算和团队绩效，以满足既定的时间表和目标。
· 通过提案开发、预算编制和客户互动支持业务发展。
· 指导和辅导初级团队成员，以支持他们的成长。
· 建立和维护与客户、合作伙伴和内部利益相关者之间的良好关系。
· 监控监管情报和沟通
查看英文原文
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
The Manager, Regulatory Registration and Compliance is responsible for developing the strategy based on regulatory requirements and for preparing/reviewing relevant Project Plans, joint operating procedures, and/or templates. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. This role also provides strategic regulatory guidance, training, coaching, and mentoring to junior members; may be required to line manage members of staff.
· Lead and coordinate complex regulatory projects, ensuring timely, high-quality delivery and compliance with regulatory requirements.
· Develop regulatory strategies, manage project setup activities, and provide expert guidance to internal and external stakeholders.
· Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other health authorities.
· Identify and mitigate risks, resolve project issues, and ensure adherence to company processes and standards.
· Manage project resources, budgets, and team performance to meet agreed timelines and objectives.
· Support business development through proposal development, budgeting, and client engagements.
· Mentor and coach junior team members to support their development.
· Build and maintain strong relationships with clients, partners, and internal stakeholders.
· Monitor regulatory intelligence and communicate relevant regulatory and legislative updates.
· Support client qualification, audit and inspection readiness, and responses to findings.
· Oversee vendor qualification and performance, ensuring compliance with company standards.
· Drive process improvements and lead departmental and organizational change initiatives.
- University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
- Experience in the pharmaceutical, CRO, or regulatory sector, including experience in a leadership or project management role
- Knowledge of Regulatory (EU) area and applicable legal and other requirements, both local and global, within pharmaceutical industry (knowledge of ICH GCP/GVP and applicable regulatory requirements)
- Excellent organizational skills with the ability to manage multiple projects and deadlines.
- A collaborative mindset, coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
- Advanced knowledge of English (both written and verbal)
- Experience with centralised procedures advantageous
- Experience with regulatory databases and dossier management software advantageous
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.