Global Regulatory Labeling Lead: Strategy & Compliance

Parexel; Jackson (MS); On-site; USD 140,000 - 210,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to shape global labeling strategy across a diverse portfolio of therapies. This role leads Target Product Label development, CCDS ownership, and regional labeling approaches while coordinating regulatory submissions and health authority interactions.

You will partner with Regulatory, Clinical, Safety, Medical and Commercial teams to ensure compliant, high-quality labeling documentation throughout the product

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.
• Urgency in FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
• Integrity and high standards for self and others.
• Results orientation and strategic orientation linking visions to daily work.

Responsibilities

• Global labeling strategy development across CCDS, US, EU, ROW and other major markets.
• Develop and maintain knowledge of labeling regulations and industry standards; communicate requirements to stakeholders.
• Lead the TPL development for early-phase assets.
• Create labeling content, format and accountability for regulatory submissions and amendments.
• Support ROW ROW labeling assessments against CCDS and HA responses.
• Coordinate labeling processes with cross-functional teams for local compliance with CCDS.
• Communicate labeling strategy, risks, mitigations and plans to leadership and teams.
• Provide input for end-to-end labeling processes.
• Lead and manage labeling team meetings and drive discussions.
• Provide coverage during peak periods or absences.

Skills

Meeting facilitation

Leadership

Communication

Regulatory strategy

Cross-functional collaboration

Medical/technical writing

Regulatory compliance

Project governance

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred (MSc/PhD/PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Trackwise

Microsoft Office / SharePoint

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to shape global labeling strategy across a diverse portfolio of therapies. This role leads Target Product Label development, CCDS ownership, and regional labeling approaches while coordinating regulatory submissions and health authority interactions.

You will partner with Regulatory, Clinical, Safety, Medical and Commercial teams to ensure compliant, high-quality labeling documentation throughout the product