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Vericel® Corporation
Vericel® Corporation
201 – 500 Employees
BiotechnologyHealthcareHealthcare Insurance
Vericel® Corporation is a biotechnology company focused on advanced cell and biological therapies for sports medicine and severe burn care in the United States. Its products include MACI, a cell therapy used in knee cartilage repair, and Epicel, a treatment for severe burns. Vericel also holds exclusive rights to NexoBrid, a biological product used to remove eschar from severe thermal burns. The company’s work spans healthcare and biotechnology, supporting teams developing, manufacturing, and bringing specialized therapies to patients.
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Senior Manager, Regulatory Affairs at Vericel (Hybrid)

Lead regulatory strategy, FDA submissions, and compliance activities for Vericel’s regenerative cell therapy products. Partner with cross-functional teams, health authorities, and external providers to advance biologics programs.

USUnited StatesMAMassachusetts
$188,000 – $205,000 / year
HybridFull-timeSeniorEnglish RequiredCompliance
Assembly

Description

  • Plan, prioritize, and independently manage regulatory activities for assigned development and commercial products
  • Create and execute regulatory strategies that support approvals, ongoing compliance, and business objectives
  • Coordinate the preparation and timely submission of INDs, BLAs, and other biologics dossiers
  • Evaluate priorities, regulatory risks, and opportunities; recommend actions and escalate significant issues with mitigation plans
  • Address evolving regulations, health authority requests, emerging product concerns, and changing business needs
  • Keep regulatory submissions aligned with applicable requirements
  • Represent Vericel in interactions with the FDA and other regulatory authorities
  • Act as regulatory lead or subject-matter expert for cross-functional project teams
  • Provide regulatory guidance across products, pathways, biologics, and combination products
  • Monitor regulatory developments and advise management on material changes
  • Help improve regulatory best practices and standard operating procedures
  • Collaborate with internal departments, CROs, and external vendors as needed
  • Report to the Director of Regulatory Affairs

Requirements

  • At least 8 years of progressive Regulatory Affairs experience in biotechnology or pharmaceuticals
  • Extensive experience supporting biologics programs
  • Proven ability to independently lead complex regulatory projects and shape strategy
  • Experience advancing cross-functional submissions to completion with limited supervision
  • Hands-on experience preparing BLA submissions, amendments, and supplements
  • Experience with prescription drug advertising requirements and promotional review committees
  • Knowledge of pharmaceutical labeling regulations
  • Working knowledge of FDA regulations, organizational structure, and functions
  • Working knowledge of eCTD components and organization
  • Excellent regulatory writing and oral communication skills
  • Ability to communicate, negotiate, and influence regulatory strategy with cross-functional colleagues, senior leaders, external partners, and health authorities
  • Strong attention to detail with the ability to work independently, act urgently, balance competing priorities, and collaborate across multidisciplinary teams and with external vendors
  • Bachelor of Science degree in a scientific field
  • Advanced degree preferred
  • Willingness to travel occasionally, approximately 5–10%

Benefits

  • Remote work available on Fridays
  • Purpose-driven opportunity supporting access to cell therapies
  • Opportunities for professional growth
  • Collaborative and supportive cross-functional environment
  • Bonus, incentive compensation, equity, and benefits may supplement base pay
  • Occasional travel of approximately 5–10%

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