Global Regulatory Labeling Strategy Lead

Parexel; Honolulu (HI); On-site; USD 150,000 - 210,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio, shaping regulatory labeling from early development to lifecycle management. You will own TPL development, CCDS, regional labeling strategies, and HA responses while collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will guide governance, communicate strategy to senior management, and ensure high-quality documentation across the product

Qualifications

• Experience facilitating meetings and driving consensus/results.
• 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 desirable.
• Experience with TPL work for early development programs and lifecycle programs.
• Strong knowledge of regulatory communication timelines (FDA/EMA/MHRA).
• Integrity and results orientation.
• Strategic orientation linking visions to daily work.
• Fluent English; additional languages an asset.

Responsibilities

• Provide strategic leadership for global labeling activities (CCDS, US, EU, ROW).
• Develop and maintain labeling regulations knowledge and communicate requirements.
• Lead TPL development for early-phase assets.
• Develop labeling content/format for regulatory submissions and ensure regulatory compliance.
• Support ROW labeling assessments and HA responses.
• Coordinate consistency of labeling processes across regions.
• Communicate labeling strategy and risks to leadership.
• Lead labeling team meetings and content management.
• Provide coverage during peak periods.

Skills

Leadership

Regulatory strategy

Global labeling

Cross-functional collaboration

Meetings facilitation

Communication (verbal/written)

Strategic thinking

Regulatory decision-making

Education

Bachelor's degree in Life Sciences

Advanced degree preferred (MSc, PhD, PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio, shaping regulatory labeling from early development to lifecycle management. You will own TPL development, CCDS, regional labeling strategies, and HA responses while collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will guide governance, communicate strategy to senior management, and ensure high-quality documentation across the product