Director of Regulatory Affairs - CMC
Global leader in the development and production of life saving pharmaceuticals seeks a Director of Regulatory Affairs - CMC to oversee a large regulatory affairs group working on chemistry and manufacturing controls throughout the company. This highly regarded company offers excellent career growth opportunities across its many divisions, both domestic and international. The Director of Regulatory Affairs - CMC will:
Be responsible for all ANDA submissions ...
Assume leadership role for pharma biologics manufacturing and fill and finish operation with division of global company.
Requires degree in chemistry, biology, engineering or similar and leadership track record in biological pharmaceutical manufacturing quality compliance
*** Management of product releases, batch record executions, batch record reviews, approval of production deviations, change controls, compliance, and investigations.
*** cGMP and GMP Quality Compliance, ...
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