Global Labeling Strategy Leader

Parexel; Annapolis (MD); On-site; USD 140,000 - 210,000; Full time

Job summary

Parexel seeks a Senior/Global Regulatory Labeling Strategist to drive global labeling strategy across its diverse portfolio of therapies. You will own CCDS and lead regulatory labeling initiatives from early development through lifecycle management, collaborating with Regulatory, Clinical, Safety and Commercial teams.

You will provide strategic leadership, oversee TPL development, annual labeling updates, and Health Authority interactions, while ensuring high-quality, compliant labeling across

Qualifications

• 7-10+ years in biotech/pharmaceutical industry with global labeling/regulatory leadership.
• Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
• Strong knowledge of current global regulations, including vaccine development regulations and registrations pathways.
• Previous experience in oncology or rare diseases is highly preferred
• Strong experience with CTD format and content regulatory filings.
• Direct experience authoring, maintaining, and governing CCDS with ownership of global labeling updates.

Responsibilities

• Provide global labeling strategy and leadership across CCDS, US, EU, and ROW.
• Lead TPL development for early-phase assets and ensure regulatory labeling requirements are met.
• Develop labeling content, format and accountability for regulatory submissions and supplements.
• Support ROW labeling assessments against CCDS and prepare Health Authority responses.
• Coordinate with global stakeholders to ensure consistency of labeling processes and compliance.
• Lead labeling team meetings and drive strategic discussions.
• Provide coverage during peak periods or for other products as needed.

Skills

Strategic leadership

Regulatory labeling expertise

Cross-functional collaboration

Medical/technical writing

Global labeling (US/EU/ROW)

Project governance

Education

Bachelor's degree in Life Sciences

MSc/PhD/PharmD preferred

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Job description

Parexel seeks a Senior/Global Regulatory Labeling Strategist to drive global labeling strategy across its diverse portfolio of therapies. You will own CCDS and lead regulatory labeling initiatives from early development through lifecycle management, collaborating with Regulatory, Clinical, Safety and Commercial teams.

You will provide strategic leadership, oversee TPL development, annual labeling updates, and Health Authority interactions, while ensuring high-quality, compliant labeling across