Senior Director Regulatory Labeling (Interim)

AL Solutions; United States; Remote; USD 132,500 - 302,500; Full time

Benefits offered by this job

Remote flexibility

Competitive compensation

Potential for contract extension or permanent hire

Job summary

A leading biopharmaceutical company seeks a Senior Director of Regulatory Labeling to drive global labeling initiatives, ensuring compliance with FDA standards and managing critical submissions. This role offers leadership over labeling processes and the chance to shape product approvals in a collaborative environment.

Qualifications

• 8+ years of experience in Regulatory Affairs with a focus on labeling.
• Proven success in leading BLA submissions and authoring USPI and CCDS.
• Strong understanding of FDA requirements.

Responsibilities

• Lead and manage global labeling initiatives.
• Ensure compliance with FDA standards.
• Collaborate across various functions for strategic consistency.

Skills

Regulatory Affairs

Labeling Strategy

Cross-Functional Collaboration

Project Management

Communication

Education

Bachelor's degree in Life Sciences or related field

Job description

Senior Director Regulatory Labeling (Interim)

Senior Director Regulatory Labeling (Interim)

Direct message the job poster from AL Solutions

Expert in connecting top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical clients across Europe and the US.

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

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Science

• Industries

  Research Services, Biotechnology Research, and Pharmaceutical Manufacturing

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