Remote Regulatory Affairs Manager — Cell & Gene

Abeona Therapeutics Inc.; Northern (KY); Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

HSA & FSA

Lifestyle Spending Account

401(k) with company match

Paid time off (up to 160 hours)

Job summary

Abeona Therapeutics Inc. in the United States is seeking a Manager, Regulatory Affairs to lead regulatory strategy and execution for investigational and commercial cell and gene therapy programs, with emphasis on CMC activities and health authority interactions.

This hands-on role requires coordinating IND/BLA submissions, maintaining timelines, and collaborating cross-functionally within a fast-paced biotech.

Qualifications

• Bachelor's degree in biology, biochemistry, pharmacy, chemistry, engineering, or related life science discipline (advanced degree preferred).
• 3–5 years of regulatory affairs experience in biopharmaceuticals; direct experience with development-stage programs.
• Experience supporting FDA interactions (meetings, packages, responses).
• Familiar with FDA regulations (21 CFR Parts 210, 211, 312, 600, 601) and CBER guidance.
• Strong written/verbal communication; ability to collaborate cross-functionally.

Responsibilities

• Coordinate INDs, IND amendments, BLAs, and related filings in eCTD format; manage submission timelines.
• Support CMC regulatory strategies for cell and gene therapy programs; document manufacturing, analytics, and control strategies.
• Prepare FDA meeting materials; respond to agency questions; maintain communication with reviewers.
• Contribute to global regulatory strategy, including interactions with EMA and other authorities.
• Assist in lifecycle management, annual reports, safety updates, and post-submission amendments.

Education

Bachelor's degree in life sciences; advanced degree preferred

Job description

Abeona Therapeutics Inc. in the United States is seeking a Manager, Regulatory Affairs to lead regulatory strategy and execution for investigational and commercial cell and gene therapy programs, with emphasis on CMC activities and health authority interactions.

This hands-on role requires coordinating IND/BLA submissions, maintaining timelines, and collaborating cross-functionally within a fast-paced biotech.