Strategic Director, Global Regulatory Labeling

POL - 6999 Takeda SCE

Warszawa

Hybrid

PLN 421,000 - 579,000

Full time

3 days ago

Be an early applicant

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Takeda in Lodz, Poland (Hybrid) is seeking a Director, Global Regulatory Labeling Strategy to shape the future of product labeling across a diverse portfolio. This highly visible role combines scientific expertise, regulatory strategy, and cross-functional leadership to deliver labeling solutions for patients, healthcare professionals, and business objectives worldwide.

You will lead global labeling strategy across development and lifecycle, author CCDS/USPI/SmPC documents, and collaborate with

Qualifications

Bachelor's degree in a scientific discipline is required.
10+ years of pharmaceutical industry experience.
Significant experience in global regulatory labeling and/or regulatory affairs.
Experience authoring CCDS, USPI, and EU SmPC documents.
Experience leading cross-functional teams and driving consensus among stakeholders.

Responsibilities

Lead global labeling strategy for multiple products across development and lifecycle.
Author and oversee CCDS, USPI, EU SmPC, and Target Labeling Profiles.
Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, Commercial, and others.
Lead discussions and present recommendations to senior governance and leadership forums.
Develop strategic labeling positions based on scientific data, regulatory precedent, and health authority expectations.
Support global implementation of labeling updates with regulatory compliance.
Partner with vendor organizations and operational teams to ensure end-to-end labeling delivery.
Serve as leadership presence within the growing Poland organization.