Global Labeling Strategy Lead — Remote

Parexel; Baton Rouge (LA); Remote; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

Parexel seeks a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. The role spans early development through post-approval lifecycle, working at the intersection of regulatory strategy, scientific communication, and product development.

You will own Target Product Label development, CCDS, regional labeling strategies, and health authority responses, driving regulatory submissions and ensuring high-quality labeling documentation

Qualifikationen

• Experience in global labeling across CCDS, US, EU, ROW and major markets.
• Strong medical/technical writing skills and ability to author regulatory content.
• Ability to lead cross-functional teams and influence stakeholders across geographies.
• Senior experience with FDA/EMA/MHRA timelines and regulatory communications.
• Proven track record delivering labeling for major regulatory submissions.

Aufgaben

• Lead global labeling strategy and governance across CCDS and regional labels.
• Develop and maintain knowledge of labeling regulations and industry standards.
• Own TPL development for early-phase assets.
• Create labeling content for regulatory submissions (MAAs) and supplements.
• Support ROW labeling assessments and HA responses.
• Coordinate with project teams to ensure CCDS consistency.
• Communicate labeling strategy and risks to senior leadership.
• Lead labeling team meetings and manage content delivery.
• Provide coverage during peak periods or absences.

Kenntnisse

Global labeling strategy

Regulatory leadership

Medical writing

Cross-functional collaboration

Regulatory strategy

Strategic communication

Ausbildung

Bachelor’s degree in Life Sciences

MSc/PhD/PharmD preferred

Tools

RIMS (Veeva RIMS)

eDMS (Veeva)

Apollo

Docubridge

TrackWise

Jobbeschreibung

Parexel seeks a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. The role spans early development through post-approval lifecycle, working at the intersection of regulatory strategy, scientific communication, and product development.

You will own Target Product Label development, CCDS, regional labeling strategies, and health authority responses, driving regulatory submissions and ensuring high-quality labeling documentation