Global Labeling Strategy Lead — Remote

Parexel; Dover (DE); Remote; USD 170,000 - 230,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to drive global labeling strategy across a diverse therapy portfolio. You will own TPL development for early assets, CCDS governance, and regional labeling plans while interacting with Regulatory, Clinical, Safety and Commercial teams worldwide.

The role offers exposure to high-impact lifecycle labeling from development through post-approval, requiring strong leadership, medical writing, and regulatory expertise to

Qualifications

• Bachelor’s degree in Life Sciences or related field; MSc/PhD/PharmD preferred.
• 7–10+ years in biotech/pharma with 5–7+ years in global labeling/regulatory leadership.
• Experience leading cross-functional teams and influencing stakeholders across geographies.

Responsibilities

• Lead global labeling strategy and governance across CCDS, US, EU, ROW, and major markets.
• Develop and maintain knowledge of labeling regulations and communicate requirements to stakeholders.
• Own TPL development for early-phase assets and oversee CCDS governance across regions.
• Prepare labeling content for regulatory submissions and ensure regulatory compliance of new text.
• Coordinate ROW labeling assessments and HA responses; ensure local labeling consistency.

Skills

Strategic leadership

Regulatory labeling strategy

Cross-functional collaboration

Medical/technical writing

Communication (verbal & written)

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree preferred (MSc, PhD, PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

APOLLO

Docubridge

Trackwise

MS Office / SharePoint

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to drive global labeling strategy across a diverse therapy portfolio. You will own TPL development for early assets, CCDS governance, and regional labeling plans while interacting with Regulatory, Clinical, Safety and Commercial teams worldwide.

The role offers exposure to high-impact lifecycle labeling from development through post-approval, requiring strong leadership, medical writing, and regulatory expertise to