Biosimilars expert in regulatory affairs

We are looking for an expert in regulatory affairs to help with our three biosimilar biologics projects. Arfe are developing them in the US and in the EU, so need expertise in the EU and U.K. Scope of work includes: 1. helping to obtain a meeting to obtain Scientific Advice from EMA; 2. help interact with US team to devise best Phase II-III protocols for PK/PD and clinical efficacy/safety; and 3. help oversee all European operational aspects of development and commercialization. We plan to have an office in Dublin, Ireland, but expert can be located anywhere in Europe to perform duties. Call if you have questions or comments.

Dr. Joseph Sinkule

U.S. Phone: (480) 254 5871 (Mountain time zone).

Skills: Research Writing, Research, Technical Writing, Report Writing, Medical

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About the Employer:
( 0 reviews ) GOODYEAR, United States

Project ID: #28242048

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