Daiichi Sankyo, Inc. jobs

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ASSOCIATE DIRECTOR, US REGULATORY AFFAIRS STRATEGY

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

CompanyDaiichi Sankyo, Inc.
AddressBasking Ridge, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted 3 weeks ago See detail

Associate Director, US Regulatory Affairs Strategy

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

Manager, Regulatory Affairs - Regulatory Project Manager

Daiichi Sankyo, Inc.

Basking Ridge, NJ

$117K - $148K a year

Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background M...

Clinical Study Manager, Global Clinical Operations

Daiichi Sankyo, Inc.

Remote

$101K - $128K a year

Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study plan provided by the CRO. Participate in site selection and site qualification with (study team and...

Manager, Contract Manufacturing Organization Management Supply Chain

Daiichi Sankyo, Inc.

Basking Ridge, NJ

$103K - $131K a year

Develop and maintain a robust relationship with CMOs as a primary contact thorough proper communication /alignment. Support Daiichi Sankyo Supply chain in managing CMOs. This includes coordinating Global demand planning, Contract/...

Quality Assurance GMP Intern

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Defining, measuring, analyzing, and improving identified processes within the quality organization. Performing data analysis for established metrics and identifying potential new metrics. Supporting continuous improvement projects...