and delivering the global Packaging and Labeling strategy for all modalities across the organization, coordinating with drug product... strategy and market applications, and represents Vertex to global regulatory agencies Represents MS&T on corporate...
Job Description General Summary: The Senior Director, Regulatory Strategy, is a regulatory leader with expert... technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible...
Job Description General Summary: The Regulatory Strategy Director will be responsible for the development.... This position will play a major role in shaping cohesive regulatory strategy for assigned programs and ensuring effective...
approvals in the US market. Expert knowledge of clinical development within US and Global regulatory strategy. Support... and interpretations of FDA. Ensure that all products comply with US regulatory requirements, including safety, efficacy, and labeling...
approvals in the US market. Expert knowledge of clinical development within US and Global regulatory strategy. Support... and interpretations of FDA. Ensure that all products comply with US regulatory requirements, including safety, efficacy, and labeling...
Manager, Regulatory Affairs - CMC Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Manager of Regulatory Affairs - CMC to join our Regulatory Affairs...
, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory...JOB TITLE: Director/Sr. Director, Regulatory Affairs – Commercial DEPARTMENT: Regulatory Affairs REPORTS TO: Vice...
clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects... regulatory strategies and responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy...
mission OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical... development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline...
and, when needed, contribute to the labeling strategy of other assets. Key Accountabilities/Responsibilities Lead labeling..., Regulatory, Quality and Supply Chain to ensure compliance Knowledge of US, EU, Japanese labeling templates and labeling sections...
. This is life-changing work, and we are all in, are you? The Medical Director is responsible for safety strategy and major safety... input and be able to author new or existing safety documents to ensure compliance with relevant regulatory requirements...
. This is life-changing work, and we are all in, are you? The Medical Director is responsible for safety strategy and major safety... input and be able to author new or existing safety documents to ensure compliance with relevant regulatory requirements...
a state-of-the-art development plan or disease area strategy that is competitive and consistent with the latest regulatory... Scientific Director: Leads, drives, or contributes to strategy for the development of assigned internal or partnered pipeline...
in various departments across the organization, such as Disease Strategy Teams, Global and North America Marketing, North America... Affairs (GMDA), Field Training, Market Research, Business Analytics, Regulatory Affairs, Public Affairs, and Corporate...
of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval... by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS...
and external collaboration to ensure PV operational excellence and regulatory compliance. The position below will be based... and implements the strategy for PV system, processes, and vendor deployment. Responsible for all PV operational aspects for entire...
, Labeling and those required for regulatory strategies, interactions, and regulatory filings. Provides resolution of clinical.... This individual will contribute to the clinical pharmacology and pharmacometrics strategy to support PDT project progression...
mission POSITION OBJECTIVES: The Associate Medical Director leads and drives strategy for the overall global... clinical development of assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory...