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FSP Senior Regulatory Affairs Consultant - CMC vaccines
Parexel International Corporation
Poland, Remote
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 skillsFluent English, French language skills are a plus
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Job posted: 2022-09-24