Senior Global Labeling Strategy Lead

Parexel; Boston (MA); Presencial; USD 140 000 - 210 000; Tempo integral

Resumo da oferta

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling initiatives across diverse therapies, from early development to lifecycle management. This role combines regulatory strategy, scientific communication, and product development to deliver compliant, high-quality labeling across markets.

You will own TPL development for early assets, CCDS ownership, and regional labeling strategies, while guiding health authority responses and supporting regulatory

Qualificações

• Experience leading regulatory labeling strategy across multiple markets.
• Proven ability to drive cross-functional consensus in matrix environments.
• Strong medical/technical writing and regulatory submissions.
• Familiarity with CCDS, CTD formats and labeling lifecycle management.

Responsabilidades

• Provide strategic leadership for global labeling activities (CCDS, TPL, regional labels).
• Lead governance committees and partner with Regulatory, Clinical, Safety and Commercial teams.
• Develop and maintain labeling content for regulatory submissions and HA responses.
• Coordinate ROW labeling assessments and downstream implementation across markets.

Conhecimentos

Leadership

Regulatory strategy

Medical writing

Cross-functional leadership

Labeling experience

Global regulatory

Formação académica

Bachelor in Life Sciences

MSc preferred

Ferramentas

Veeva RIMS

eDMS

Trackwise

Microsoft Office

Descrição da oferta de emprego

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling initiatives across diverse therapies, from early development to lifecycle management. This role combines regulatory strategy, scientific communication, and product development to deliver compliant, high-quality labeling across markets.

You will own TPL development for early assets, CCDS ownership, and regional labeling strategies, while guiding health authority responses and supporting regulatory