Global Regulatory Labeling Strategy Lead

Takeda; Warszawa; Sur place; PLN 320 000 - 520 000; Plein temps

Résumé du poste

Takeda in Warsaw is seeking an Associate Director, Global Regulatory Labeling Strategy, to lead global labeling development for innovative products across development and commercialization. You will partner with Clinical, Safety, Medical Affairs, Commercial and Regulatory teams to shape labeling strategy, manage CCDS, USPI, SmPC, and oversee cross-functional governance.

This role requires deep regulatory expertise, strong leadership, and the ability to drive submissions and negotiations with

Qualifications

• Bachelor’s degree in a scientific discipline (or equivalent experience).
• 8+ years of pharmaceutical industry experience.
• At least 6 years of labeling experience or 5+ years in regulatory affairs.
• Strong knowledge of US and EU labeling regulations and requirements.
• Experience developing and maintaining USPI, EU SmPC, CCDS, and related labeling documentation.

Responsabilités

• Lead Global Labeling Strategy for assigned products.
• Coordinate approval processes through governance forums and stakeholders.
• Develop, update, and maintain labeling documents (CCDS, TLP, USPI, EU SmPC).
• Support health authority negotiations and regulatory submissions.

Connaissances

Strategic thinking

Cross-functional leadership

Regulatory affairs leadership

Stakeholder management

Data-driven decision making

Influence and negotiation

Formation

Bachelor's degree in a scientific discipline

MSc/PhD/PharmD preferred

Outils

USPI

EU SmPC

CCDS

Description du poste

Takeda in Warsaw is seeking an Associate Director, Global Regulatory Labeling Strategy, to lead global labeling development for innovative products across development and commercialization. You will partner with Clinical, Safety, Medical Affairs, Commercial and Regulatory teams to shape labeling strategy, manage CCDS, USPI, SmPC, and oversee cross-functional governance.

This role requires deep regulatory expertise, strong leadership, and the ability to drive submissions and negotiations with