Senior Manager, Regulatory Affairs
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.
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