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Generics/Biosimilars, IP, Regulatory and Clinical

At generic companies Intellectual Property (IP) management activities such as freedom to operate and planning are more important compared to other related life science industries. The search for regulatory affairs positions for companies active in the bio-generic field have specific requirements in terms of experience and personality as this is a relative new, still dynamic and political influenced regulatory field.

 

Clinical development for generic products is often based on bio-equivalent studies.

 

Some recent assignments were:

- IP Manager Biosimilars worldwide, main generic company

- RA Manager, generic company

- Regulatory Head, specialty generic company

- Director Clinical Development and Pharmacokinetics, generic 

- Head of Development, generics company

- Clinical Project Manager, therapeutic generics

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