Global Regulatory Labeling Strategy Lead

Parexel; Atlanta (GA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy and governance across a diverse portfolio of therapies. You will own TPL development for early assets, CCDS, and regional labeling strategies, interfacing with Regulatory, Clinical, Safety, Medical and Commercial teams to ensure compliant, high-quality labeling documentation.

The role requires senior leadership, strong communication, and cross-functional collaboration across global markets.

Qualifikationen

• Experience facilitating meetings and driving consensus/results.
• Proven ability in medical/technical writing for labeling content.
• Labeling experience across CCDS, US, EU, ROW markets; vaccines/oncology/rare disease desirable.
• Ability to lead and influence global labeling strategy and governance.
• Strong knowledge of current global regulations and regulatory submissions.

Aufgaben

• Provide strategic leadership for global labeling activities across CCDS, US, EU, ROW.
• Lead TPL development for early-phase assets.
• Develop labeling content and ensure regulatory compliance for submissions.
• Support ROW labeling assessments and HA responses.
• Lead labeling governance meetings and cross-functional collaboration.
• Manage labeling team discussions and coverage during peak periods.

Kenntnisse

Leadership

Communication

Collaboration

Medical/technical writing

Regulatory strategy

Meeting facilitation

Strategic orientation

Cross-functional teamwork

Ausbildung

Bachelor’s degree in Life Sciences or related field

MSc/PhD/PharmD preferred

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

MS Office / SharePoint / Acrobat

Jobbeschreibung

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy and governance across a diverse portfolio of therapies. You will own TPL development for early assets, CCDS, and regional labeling strategies, interfacing with Regulatory, Clinical, Safety, Medical and Commercial teams to ensure compliant, high-quality labeling documentation.

The role requires senior leadership, strong communication, and cross-functional collaboration across global markets.