Senior Global Regulatory Labeling Strategy Lead

Parexel; Des Moines (IA); On-site; USD 120,000 - 160,000; 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. This role spans pre‑development through post‑approval, integrating regulatory strategy with scientific communication and product development.

You will own TPL development, CCDS, regional labeling, HA responses, and cross‑functional governance, guiding teams worldwide to compliant labeling solutions. EST time zones preferred.

Qualifications

• Experience leading global labeling strategies and governance.
• Strong medical/technical writing capabilities for CCDS and labeling texts.
• Familiarity with major markets (US/EU/ROW) labeling requirements.
• Proven record of cross-functional leadership and stakeholder influence.
• Ability to manage lifecycle labeling from development to post‑approval.

Responsibilities

• Lead global labeling strategy and governance activities.
• Own Target Product Label (TPL) development for early assets and CCDS.
• Develop labeling content for regulatory submissions and amendments.
• Coordinate ROW labeling assessments and HA responses.
• Communicate strategy and risks to leadership and teams.
• Provide regulatory labeling input across product lifecycle.

Skills

Global labeling strategy

Regulatory leadership

Cross-functional collaboration

Medical/technical writing

Strategic thinking

Risk assessment & mitigation

Project governance

Communication skills

Regulatory strategy development

CTD experience

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree (MSc/PhD/PharmD) preferred

Tools

RIMS (Veeva RIMS)

eDMS (Veeva)

Apollo

Docubridge

Change Management systems (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. This role spans pre‑development through post‑approval, integrating regulatory strategy with scientific communication and product development.

You will own TPL development, CCDS, regional labeling, HA responses, and cross‑functional governance, guiding teams worldwide to compliant labeling solutions. EST time zones preferred.