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Regulatory Affairs - Recruitment Consultant

Job Title: Senior Manager Regulatory Affairs

A leading American biopharmaceutical company in the Greater Boston area is seeking a Senior Manager of Regulatory Affairs (BLA) to join its growing team. This organization specializes in cellular therapies and specialty biologic products, with a strong focus on regenerative medicine for sports injuries and burn care. The company operates from a newly built facility and is preparing to launch several new projects in mid-next year.

Key Responsibilities:

• Lead the development and execution of regulatory strategies for biologic products.
• Prepare, manage, and submit INDs, BLAs, and other regulatory filings in compliance with FDA requirements.
• Serve as a regulatory subject matter expert on cross-functional teams, providing strategic input and guidance.
• Ensure all labeling and promotional materials meet regulatory standards.
• Monitor evolving regulatory trends and maintain up-to-date knowledge of applicable guidelines and best practices.
• Represent the company in interactions with regulatory authorities, including the FDA.

Qualifications:

• Bachelor's degree in a scientific discipline (advanced degree preferred).
• 5-7 years of regulatory affairs experience, specifically in biologics.
• Proven experience with BLA submissions, labeling, and promotional review processes.
• Familiarity with FDA structure, eCTD format, and combination product regulations.
• Strong written and verbal communication skills, with the ability to collaborate effectively across departments.
• A proactive, detail-oriented mindset with a passion for improving patient outcomes through innovative therapies.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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