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Vericel® Corporation
Vericel® Corporation
201 – 500 Angajați
Asigurare de sănătateAsistență medicalăBiotehnologie
Vericel® Corporation este o companie de biotehnologie axată pe terapii celulare și biologice avansate pentru medicina sportivă și îngrijirea arsurilor severe în Statele Unite. Produsele sale includ MACI, o terapie celulară utilizată pentru repararea cartilajului genunchiului, și Epicel, un tratament pentru arsurile severe. Vericel deține, de asemenea, drepturi exclusive pentru NexoBrid, un produs biologic utilizat pentru îndepărtarea escarei din arsurile termice severe. Activitatea companiei acoperă domeniile sănătății și biotehnologiei, sprijinind echipele care dezvoltă, produc și aduc terapii specializate pacienților.
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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.

USStatele Unite ale AmericiiMAMassachusetts
188.000 $ – 205.000 $ / an
HibridNormă întreagăSeniorLimbă Obligatorie: englezăConformitate
Limbaj de asamblare

Descriere

  • 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

Cerințe

  • 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%

Beneficii

  • 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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