The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products.... Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area...
of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions. This position ensures.... Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned...
Experience Qualifications 7 or More Years in the pharmaceutical industry 4 or More Years in regulatory affairs, NDA, sNDA, BLA... with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support...
and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs... assigned to alliance assets for operational matters. Responsibilities: Develop and implement US regulatory strategy...
Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global... regulatory strategy and tactical planning for assigned microbiology on market products or those products in development...
, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regional Marketing... adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible...
Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health... and immune disorders. Job Summary The primary responsibilities of this position are to guide the strategy and to lead the...
as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member... with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares content...