Global Regulatory Labeling Strategist - Remote

Parexel; Bismarck (ND); Remote; USD 150,000 - 230,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse therapies portfolio. This high-visibility role oversees TPL development, CCDS, regional strategies, and regulatory responses, partnering with Regulatory, Clinical, Safety, Medical, and Commercial teams worldwide.

The role requires extensive experience in global labeling, regulatory submissions, and cross-functional leadership, with strong medical writing and communication

Qualifications

• Must have facilitation experience and ability to drive consensus.
• Strong leadership, communication and collaboration skills.
• Proven medical/technical writing capability.
• Labeling experience across CCDS/US/EU/UK and other markets in rare diseases, oncology or vaccines.
• Experience with TPL for early development and lifecycle programs.
• Awareness of FDA/EMA/MHRA timelines and regulatory communications.
• Demonstrates integrity and high standards.
• Results-oriented with strategic mindset.
• Ability to align strategy with daily work and project goals.
• Experience working in global, cross-cultural teams and with affiliates/third parties.

Responsibilities

• Lead global labeling strategy and governance across CCDS and regional labeling.
• Own TPL development for early-stage assets.
• Develop labeling content and ensure regulatory submissions meet requirements.
• Support ROW labeling assessments and health authority responses.
• Coordinate with cross-functional teams to ensure CCDS alignment and local compliance.
• Communicate strategy, risks, and plans to leadership and teams.
• Contribute to end-to-end labeling processes and decision making.
• Lead labeling team meetings and manage content.
• Provide coverage during peak periods or member absence.

Skills

Meeting facilitation

Leadership & communication

Medical writing

Labeling experience

TPL experience

Regulatory timelines

Integrity

Results oriented

Strategic thinking

Cross-functional collaboration

Adaptability

Teamwork

Education

Bachelor’s in Life Sciences

Advanced degree preferred

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

TVT

Promomats

GLAMS

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse therapies portfolio. This high-visibility role oversees TPL development, CCDS, regional strategies, and regulatory responses, partnering with Regulatory, Clinical, Safety, Medical, and Commercial teams worldwide.

The role requires extensive experience in global labeling, regulatory submissions, and cross-functional leadership, with strong medical writing and communication