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FSP Regulatory Affairs Consultant - CMC vaccines

职位编号 R0000003864 工作地点 波蘭 职位描述

We are currently looking for a client dedicated Regulatory Affairs Consultant with CMC vaccines experience.

In the role of a Regulatory Affairs Consultant you will have strong technical skills and may be developing specialist knowledge of a particular subject and/or market. You will ensure the timely performance of work within a project scope to the quality expectations of the client. When serving as a Project Lead or Work Stream Lead, you will assure the work of the entire team or work stream is delivered on time and that it meets client’s and quality expectations.

This role can be based in Poland, Hungary, Romania or Lithuania - office or home based.

Job Responsibilities:

  • 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 5 years CMC experience, with vaccines preferred

  • Module 3 Authoring Experience, preferred

  • 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