Objective / Purpose: Responsible for the development and implementation of labeling content and strategy of multiple...-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross...
with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key role in the PDT R...&D organization accountable for the development and implementation of labeling content and strategy of multiple products in various...
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...
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...
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...
systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products. Experience.... Oversee the drug substance (DS), drug product (DP), reference standard, and packaging/labeling/serialization contract service...
, 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...
. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: The Senior Medical Director leads and drives strategy... for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory...
the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing... of regulatory submissions and collecting related CMO source documents Review and approve Annual Product Reviews (Vendor...