Global Regulatory Labeling Lead — Remote Strategy Expert

Parexel; Springfield (IL); On-site; USD 180,000 - 210,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio. This role combines regulatory strategy, scientific writing, and product development oversight to drive compliant, high-quality labeling across markets.

The position involves hands-on ownership of TPL development for early-stage assets, CCDS maintenance, and regional labeling strategies, with exposure to major regulatory applications and Health Authority

Qualifications

• Experience leading global labeling strategy across CCDS, US, EU, ROW and major markets.
• Proven medical/technical writing能力 for regulatory submissions and responses.
• Strong leadership and cross-functional collaboration with Regulatory, Clinical, Safety, Medical, and Commercial teams.
• Familiarity with CTD format and regulatory filings; ownership of CCDS labeling updates.
• Ability to manage labeling governance and provide strategic direction.”
• Fluency in English; additional languages are a plus.

Responsibilities

• Lead global labeling strategy and governance for CCDS, US, EU, ROW, and major markets.
• Own TPL development for early-phase assets and coordinate CCDS labeling updates.
• Develop labeling content and ensure regulatory submissions meet requirements.
• Provide ROW ROW assessments and HA responses in labeling projects.
• Communicate strategy, risks, and plans to leadership and cross-functional teams.
• Lead labeling team meetings and drive strategic discussions.

Skills

Leadership

Communication

Medical writing

Regulatory strategy

Collaboration

Results orientation

Strategic thinking

Teamwork

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred (MSc/PhD/ PharmD)

Tools

RIMS (Veeva)

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. This role combines regulatory strategy, scientific writing, and product development oversight to drive compliant, high-quality labeling across markets.

The position involves hands-on ownership of TPL development for early-stage assets, CCDS maintenance, and regional labeling strategies, with exposure to major regulatory applications and Health Authority