Regulatory Affairs Manager

Job Description

Global Labeling Strategy Lead (Contract)

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

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

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

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

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

Experience

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

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

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• Bachelor’s degree in Science, Medicine, Pharmacy, or related field
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• Advanced degree advantageous but not required
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Why This Role

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

Apply via LinkedIn or contact us directly for a confidential discussion .