Senior Regulatory Strategy Lead - Biologics/IND-BLA

Vericel Corporation; Burlington (MA); On-site; USD 188,000 - 205,000; Full time

Job summary

Vericel Corporation in Burlington, MA is seeking a Senior Manager, Regulatory Affairs to oversee regulatory submissions and strategy across biologics and combination products. The role requires leadership across cross-functional teams and independent management of complex regulatory programs.

You will drive IND/BLA submissions, guide regulatory strategy, and ensure alignment with FDA and global requirements, shaping a growing portfolio in cell therapies.

Qualifications

• 8+ years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical industries, including substantial biologics work.
• Experience independently leading complex regulatory projects and cross-functional submissions with limited oversight.
• Ability to adapt to changing regulatory priorities and ensure compliance and deliverable quality.
• Experience with combination products and/or botanicals is a plus.
• Experience with BLA submissions and accompanying amendments/supplements.

Responsibilities

• Plan, prioritize, and manage regulatory activities across development and commercial products.
• Lead assembly and timely submission of INDs, BLAs, and other regulatory dossiers.
• Assess priorities, identify risks, and provide regulatory guidance with proposed solutions.
• Respond to health authority requests and changing regulatory requirements.
• Represent the company with FDA and other regulatory authorities; provide cross-functional leadership on regulatory matters.

Skills

Regulatory strategy

Regulatory submissions

FDA interactions

Regulatory writing

Cross-functional leadership

Biologics experience

Education

Bachelor of Science in a scientific discipline

Advanced degree (preferred)

Job description

Vericel Corporation in Burlington, MA is seeking a Senior Manager, Regulatory Affairs to oversee regulatory submissions and strategy across biologics and combination products. The role requires leadership across cross-functional teams and independent management of complex regulatory programs.

You will drive IND/BLA submissions, guide regulatory strategy, and ensure alignment with FDA and global requirements, shaping a growing portfolio in cell therapies.