Global Regulatory Labeling Strategy Lead – Remote

Regulatory Jobs; Massachusetts; Remoto; USD 154.000 - 243.000; Tempo integral

Resumo da vaga

Takeda, in Massachusetts (Virtual), seeks an Associate Director for Global Regulatory Labeling Strategy. Lead cross-functional teams to develop and implement global labeling content, including TLPs, CCDSs, USPI, and EU SmPCs, ensuring scientific accuracy and regulatory compliance.

You will drive alignment with global stakeholders, manage labeling reviews, implement plans with new data, and negotiate with Health Authorities to support end-to-end label development.

Qualificações

• Bachelor’s degree in a scientific discipline required.
• Eight or more years of pharmaceutical industry experience, including: Six years of labeling experience; or Five or more years of regulatory or related experience.
• Experience creating, revising, or updating global product labeling, including CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles with limited supervision and guidance.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.

Responsabilidades

• Independently lead cross-functional labeling teams, driving collaboration and alignment on global labeling strategy and content.
• Coordinate the labeling approval process through the Global Labeling Oversight Committee (GLOC).
• Prepare and align GLOC chairs, members, and their respective functions for labeling reviews and decisions.
• Author and manage new and revised TLPs, CCDSs, USPIs, EU SmPCs, and other labeling documents for assigned products.
• Develop and execute labeling implementation plans that incorporate new data and Health Authority feedback.
• Coordinate global labeling sub-functions to support end-to-end label development and negotiations.
• Lead or support labeling negotiations with Health Authorities in collaboration with the Global Regulatory Lead.
• Interpret and ensure compliance with regulatory requirements in labeling content and processes.
• Manage alignment of local labeling with the CCDS and assess local exceptions.
• Support local affiliates in responding to Health Authority requests and labeling needs.
• Identify labeling risks and propose mitigation strategies to leadership.
• Build partnerships across Clinical, Safety, Medical Affairs, Commercial, and Regulatory teams.

Conhecimentos

Project management

Cross-functional leadership

Regulatory labeling

Communication skills

Negotiation

Stakeholder management

Global regulatory experience

Formação

Bachelor's degree in science

Advanced degree (MSc/PhD/PharmD)

Descrição da vaga

Takeda, in Massachusetts (Virtual), seeks an Associate Director for Global Regulatory Labeling Strategy. Lead cross-functional teams to develop and implement global labeling content, including TLPs, CCDSs, USPI, and EU SmPCs, ensuring scientific accuracy and regulatory compliance.

You will drive alignment with global stakeholders, manage labeling reviews, implement plans with new data, and negotiate with Health Authorities to support end-to-end label development.