Job Description

Global Labeling Strategy Lead (Contract)

Do not wait to apply after reading this description a high application volume is expected for this opportunity.

Global Pharmaceutical Company

EST timezone (remote) - US based

Full-time | 6-month contract

Competitive hourly rate

Start: ASAP

The Opportunity

A global pharmaceutical organisation is seeking an experienced, senior labelling leader to take end-to-end ownership of global product labelling across a defined portfolio.

This is a hands-on leadership role with genuine accountability - not a support or execution-only position. You will act as the global steward for core and major-market labelling , shaping how data is translated into claims, guiding lifecycle decisions, and balancing regulatory risk with commercial objectives.

Key Responsibilities

Global Labelling Ownership

• Own and maintain global Core Data Sheets (CCDS) and associated patient information
• Lead translation of global data into major-market labels (e.g. US PI, EU SmPC)
• Manage global vs local deviations and support Health Authority interactions
• Lead complex labelling updates across the product lifecycle

Strategy & Lifecycle Input

• Develop and maintain Target Product Labelling (TPL) to support development and regulatory positioning
• Conduct competitive labelling analyses and regulatory precedent assessments
• Provide labelling input to global regulatory strategy and major submissions

Governance & Cross-Functional Leadership

• Chair or lead cross-functional Product Labelling Teams
• Escalate key issues through formal governance pathways as required
• Partner closely with Regulatory, Medical, Safety, Clinical, and Commercial teams
• Review and approve promotional and non-promotional materials for compliance with core labelling and applicable codes

Scientific & Regulatory Judgement

• Critically evaluate clinical and non-clinical data for labelling adequacy
• Interpret evolving FDA / EMA guidance impacting labelling strategy
• Balance regulatory compliance, business needs, and risk

Candidate Profile

Experience

• 7–10+ years' experience in Regulatory Affairs with significant global labelling responsibility
• Proven ownership of CCDS and major-market labels (US and EU)
• Experience supporting regulatory submissions in key markets
• Strong background in TPL development and lifecycle labelling strategy

Capabilities

• Senior-level judgement and decision-making
• Comfortable leading in complex, matrixed global environments
• Able to influence cross-functional stakeholders at all levels
• Clear, confident scientific and regulatory communicator

Education

• Bachelor's degree in Science, Medicine, Pharmacy, or related field
• Advanced degree advantageous but not required

Why This Role

• True global ownership , not regional execution
• Strategic influence over claims, positioning, and submissions
• High-impact contract role with senior-level accountability
• Flexible working arrangement

Interested? xhyhwjd

Apply via LinkedIn or contact us directly for a confidential discussion

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