Global Regulatory Labeling Strategist - Remote

Parexel; Carson City (NV); On-site; USD 180,000 - 240,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own Target Product Label development for early assets, CCDS, and regional labeling strategies, interfacing with Regulatory, Clinical, Safety, Medical, and Commercial teams.

This role requires delivering compliant labeling documentation throughout the lifecycle, leading governance committees, and guiding health authority responses.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 7+ years in biotech/pharmaceutical industry with global labeling/regulatory leadership experience.
• Experience with CCDS, US/EU labeling and global regulatory submissions.

Responsibilities

• Lead global labeling strategy across CCDS, US, EU, ROW, and major markets.
• Develop and maintain labeling regulations knowledge; communicate requirements to stakeholders.
• Lead TPL development for early-phase assets.

Skills

Leadership

Cross‑functional leadership

Regulatory knowledge

Medical/technical writing

Strategic thinking

Communication

Problem solving

Team collaboration

Education

Bachelor’s degree in Life Sciences

MSc/PhD/PharmD preferred

Tools

RIMS (Veeva RIMS)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

TVT

Promomats

GLAMS

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own Target Product Label development for early assets, CCDS, and regional labeling strategies, interfacing with Regulatory, Clinical, Safety, Medical, and Commercial teams.

This role requires delivering compliant labeling documentation throughout the lifecycle, leading governance committees, and guiding health authority responses.