Senior Global Labeling Strategy Architect

Parexel; Juneau (AK); On-site; USD 170,000 - 230,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy from development through lifecycle management. You will own TPL development for early assets, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams to ensure compliant, high-quality labeling across markets.

You will guide governance, manage labeling content, and oversee responses to Health Authorities, while shaping strategic decisions

Qualifications

• Experience facilitating meetings and driving consensus.
• 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.
• Interact effectively as a member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties.
• Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups.
• Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues.

Responsibilities

• Global labeling strategy to support CCDS, US, EU, ROW, and major markets.
• Develop and maintain knowledge of labeling regulations and communicate requirements to stakeholders.
• Lead the TPL development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions (MAAs) and supplements.
• Support ROW labeling assessments against CCDS and HA responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance.
• Communicate regulatory labeling strategy, risks, and plans to leadership and teams.
• Provide input for end-to-end labeling processes.
• Lead labeling team meetings and drive strategic discussions.
• Provide coverage on other products during peak periods.

Skills

Leadership

Communication

Medical writing

Regulatory strategy

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

RIMS

eDMS (Veeva)

TrackWise

APOLLO

Docubridge

Microsoft Office

SharePoint

Adobe Acrobat

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy from development through lifecycle management. You will own TPL development for early assets, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams to ensure compliant, high-quality labeling across markets.

You will guide governance, manage labeling content, and oversee responses to Health Authorities, while shaping strategic decisions