Global Regulatory Labeling Lead — Strategy & Lifecycle

Parexel; Montgomery (AL); On-site; USD 150,000 - 210,000; Full time

Job summary

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through post‑approval. You will own TPL development, CCDS, and regional labeling strategies.

You will partner with Regulatory, Clinical, Safety, Medical and Commercial teams, drive governance, ensure compliant, high‑quality labeling documentation, and influence product development and global lifecycle decisions.

Qualifications

• Experience facilitating meetings and driving consensus.
• Excellent leadership, communication 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 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 and strategic orientation: link visions with daily work.

Responsibilities

• Provide global labeling strategy and governance for CCDS and regional labeling.
• Lead the TPL development for early‑phase assets.
• Develop labeling content for regulatory submissions (MAAs) and amendments.
• Support ROW labeling assessments and HA responses.
• Coordinate CCDS with regional labels for local compliance.
• Communicate strategy, risks and plans to leadership and teams.
• Lead labeling team meetings and drive strategic discussions.
• Provide coverage during peak periods or absences.
• Collaborate with cross‑functional teams to ensure labeling consistency.

Skills

Global labeling strategy

Leadership

Communication

Collaboration

Medical/technical writing

Regulatory strategy

Education

Bachelor’s degree in Life Sciences or related field

MSc/PhD/PharmD preferred

Tools

Veeva RIMS

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

Job description

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through post‑approval. You will own TPL development, CCDS, and regional labeling strategies.

You will partner with Regulatory, Clinical, Safety, Medical and Commercial teams, drive governance, ensure compliant, high‑quality labeling documentation, and influence product development and global lifecycle decisions.