Takeda Pharmaceutical Company

Senior Manager, Global Regulatory Labeling Strategy - Remote

Takeda Pharmaceutical Company(5 months ago)

RemoteFull TimeManager$137,000 - $215,270Regulatory Affairs
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About this role

A Senior Manager, Global Regulatory Labeling Strategy at Takeda is responsible for the development and implementation of labeling content and overall labeling strategy for assigned pharmaceutical products across stages of drug development, ensuring consistency across TLP, CCDS, USPI and EU SmPC. The role partners with global regulatory and cross-functional teams and interfaces with senior management to align global labeling approaches. It is part of Takeda’s R&D organization focused on delivering transformative therapies to patients.

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Required Skills

  • Labeling Strategy
  • Regulatory Writing
  • Labeling Negotiation
  • Project Management
  • Cross-Functional Leadership
  • Health Authority Submissions
  • Vendor Management
  • Stakeholder Management
  • Precedent Analysis
  • Regulatory Guidance

Qualifications

  • BSc
  • BA
  • MSc
  • PhD
  • PharmD
Takeda Pharmaceutical Company

About Takeda Pharmaceutical Company

takeda.com

Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.

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