Senior Director Regulatory Labeling; Interim

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About the Opportunity

We are partnering with an innovative biopharmaceutical company to identify a highly skilled Senior Regulatory Labeling Strategist to lead and manage global labeling initiatives, with a strong focus on USPI development, BLA submission support, and cross-functional labeling strategy.

This is a critical, high-impact role with full ownership of the labeling process, spanning initial development through lifecycle updates. You’ll be an integral part of the regulatory and clinical submission team, ensuring compliance with FDA standards and supporting product approvals.

Key Responsibilities

Regulatory Labeling Strategy and Development

• Assess and optimize existing USPI SOPs and related labeling processes.
• Lead US Labeling Working Group meetings with cross-functional stakeholders.
• Drive regulatory labeling strategy and author core labeling documents, including USPI and CCDS, ensuring compliance with FDA guidance and industry best practices.
• Prepare all labeling components in support of BLA submissions.
• Ensure labeling timelines are synchronized with regulatory milestones.

Integration of Safety and Efficacy Data

• Incorporate clinical and pivotal trial data to develop an accurate and competitive product label.
• Monitor and update labeling content as new clinical, safety, or regulatory data becomes available.

Cross-Functional Collaboration

• Work closely with teams across Clinical, Regulatory, Medical Affairs, Safety, Commercial, Quality, and Manufacturing to ensure alignment and consistency in labeling strategy.

Training and Education

• Deliver internal training and guidance on labeling best practices, FDA expectations, and regulatory updates.

Regulatory Authority Interactions

• Support FDA interactions during BLA review and throughout the submission lifecycle.
• Draft responses to labeling-related questions from regulatory authorities and participate in labeling negotiations.

Qualifications

• 8+ years of Regulatory Affairs experience with a strong emphasis on labeling strategy and US regulatory submissions.
• Proven success leading labeling development for BLAs, including authoring of USPI and CCDS documents.
• Deep understanding of FDA labeling requirements and experience participating in Health Authority interactions.
• Excellent communication, project management, and cross-functional collaboration skills.
• Prior experience in a biotech/pharma company or regulatory consultancy is strongly preferred.

What We Offer

• Opportunity to lead critical labeling strategy for high-priority regulatory filings.
• Remote flexibility and collaborative work culture.
• Competitive compensation, with potential for contract extension or permanent hire.

• Seniority level Director

• Employment type
  
  Contract

• Job function
  
  Research and Science
• Industries Research Services, Biotechnology Research, and Pharmaceutical Manufacturing

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