你准备好通过认真对待自己的工作，表现出同理心，用心行动，从而在医疗行业中获得成功吗？当我们的价值观保持一致时，我们的成就是无限的。我们与全球50强制药公司，全球顶级生物技术公司以及数百家小型和新兴公司合作。 我们为当代最重要的一些治疗方式的研发提供帮助， 包括目前市场上几乎所有的50种最畅销的药物。加入我们，你将在数百万人的生活中产生深远的影响。我们不只是拥有专业知识，我们更是用心在工作。
FSP Senior Regulatory Affairs Consultant - CMC vaccines现在申请 职位编号 R0000003863 工作地点 波蘭 职位描述
We are currently looking for a client dedicated Senior Regulatory Affairs Consultant with CMC vaccines experience.
In the role of a RA Senior Consultant you will develop specialist knowledge of a particular subject matter or market. You will provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You may serve either as an individual contributor, a workstream lead or provides overall project leadership. You will ensure the timely performance of work within a project scope to the quality expectations of PC and the client.
This role can be based in Poland, Hungary, Romania or Lithuania - office or home based.
Coordination/authoring of Module 2.3 and Module 3 dossiers, including new registration dossiers of 2 new vaccines, minor and major variations on various products with declination to other markets, renewals, PQVAR, US and CA Annual Reports
Coordination of CMC Module 1 submission, including WHO submissions, PQVAR activities, APR for all products
Lead/Coordination of a team of CMC professionals
Skills and Experience required for the role:
University degree in a science discipline
At least 7 years CMC vaccines experience
SME M3 Authoring Experience
Specific CMC LCM expertise in supporting Major/Minor Variations, Renewals and HA RTQs, M1 authoring
Working knowledge of Regulatory Systems (Veeva Vault, Veeva RIM, etc.)
Very good project management skills
Fluent English, French language skills are a plus