We are a newly licensed, west coast-based US subsidiary of a European pharmaceutical company that is seeking to hire a Head Regulatory Affairs US. This position will be US-based, and have responsibility for all FDA related activities, including review and filing of ANDA applications and on-going contact with the FDA for all correspondence related to the ANDA applications. The position reports to the Director International Regulatory Affairs and will serve as the registered US agent, if required, for the two FDA inspected and compliant foreign establishment registrations where a broad range of FDF products will be manufactured for US import and distribution in the US retail and institutional markets.
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