Regulatory Affairs Associate Ii jobs at Teva in United States, East Bradford Township
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United States
State
East Bradford Township
12 jobs found
12.07.2024
T
Teva Regulatory Affairs Associate II United States, Pennsylvania, East Bradford Township
With support from the supervisor, is responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements. Participates in cross functional teams including Global Regulatory...
The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory strategies to support development of innovative biologic products, as well as to ensure efficient management...
Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the...
Perform routine manufacturing operations related to Downstream Manufacturing such as column chromatography, viral inactivation, viral reduction filtration, UF/DF, bulk drug substance fill, and cleaning and disinfection of materials and equipment....
Perform routine cell culture maintenance & seed culture expansion based on study plans at various scales, including (but not limited to) shaker flasks, Ambr 250, 3, 50, 100 and 200L...
Participate in planning, development, implementation and ongoing management of cross study, cross functional, operational and system related projects. Supporting department related tasks and projects by collaborating with all identified stakeholders-...
With support from the supervisor, is responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements. Participates in cross functional teams including Global Regulatory...
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