Global Regulatory Labeling Lead - Plasma-Derived Therapies

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda Cambridge, MA seeks a Global Regulatory Labeling Strategy Lead (Associate Director) to orchestrate labeling strategies across CCDS, US and EU regions. You will steer cross‑functional teams, interpret clinical and regulatory data, and ensure compliance with health authority requirements for drug and device labeling.

The role demands deep experience in global labeling, leadership capabilities, and a track record of delivering strategic labeling solutions in biopharma, including

Qualifications

• Minimum of 7–10 years in biopharmaceutical labeling or related regulatory fields.
• 5–7 years direct experience in global US/EU labeling roles preferred.
• Experience with plasma-derived therapies and biologics is desirable.
• Bachelor’s or Master’s degree required; advanced degree preferred.
• Expertise in development and maintenance of core labeling documents (USPI, SmPC).

Responsibilities

• Lead global labeling strategy for PDT BU, including CCDS, US and EU labels.
• Formulate and implement innovative labeling strategies to support product development and lifecycle management.
• Provide guidance on labeling requirements, templates, and health authority guidance.
• Lead CCDS, US, and EU Labeling Teams; manage cross-functional labeling projects.
• Collaborate with Regulatory Intelligence to monitor regulatory changes affecting labeling.

Skills

Regulatory labeling strategy

Global regulatory knowledge

Cross-functional leadership

Biopharmaceutical industry experience

Leadership of labeling teams

Education

Bachelor’s or Master’s degree

Advanced scientific/health sciences degree

Tools

Electronic Document Management Systems

End-to-End Labeling Tracking Systems

Job description

Takeda Cambridge, MA seeks a Global Regulatory Labeling Strategy Lead (Associate Director) to orchestrate labeling strategies across CCDS, US and EU regions. You will steer cross‑functional teams, interpret clinical and regulatory data, and ensure compliance with health authority requirements for drug and device labeling.

The role demands deep experience in global labeling, leadership capabilities, and a track record of delivering strategic labeling solutions in biopharma, including