Global Regulatory Labeling Strategy Leader

Parexel; Madison (WI); On-site; USD 120,000 - 180,000; 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 TPL development for early assets, CCDS governance, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

Based in the United States, you will drive submissions, health authority responses, and labeling updates across major markets, guiding teams through lifecycle stages from

Qualifications

• Experience facilitating meetings and driving consensus and results.
• Excellent leadership, communication (verbal and written) and collaboration skills.
• Proven ability in medical/technical writing.
• Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
• Experience with TPL work for early development programs and identified life‑cycle programs.
• Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
• Integrity: overriding commitment to integrity and high standards for self and others.
• Results orientation
• Strategic orientation: ability to link company and departmental visions with daily work

Responsibilities

• Provide strategic leadership for global labeling activities and governance across CCDS, US, EU, ROW, and major markets.
• Lead the development of Target Product Label (TPL) for early‑phase assets and CCDS ownership.
• Develop labeling content, format, and accountability for regulatory submissions and amendments.
• Support ROW labeling assessments and Health Authority responses.
• Coordinate cross‑functional labeling processes and ensure CCDS alignment across regions.
• Communicate labeling strategy, risks, and plans to leadership and partners.

Skills

Leadership

Regulatory strategy

Medical writing

Global labeling

Cross-functional

Project management

Communication

Education

Bachelor's in Life Sciences

Tools

RIMS (Veeva)

eDMS (Veeva)

TrackWise

Microsoft Office

SharePoint

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 TPL development for early assets, CCDS governance, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

Based in the United States, you will drive submissions, health authority responses, and labeling updates across major markets, guiding teams through lifecycle stages from