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FSP Senior Regulatory Affairs Consultant - CMC vaccines

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.

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 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