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Summit Therapeutics, Inc.
Summit Therapeutics, Inc.
201 – 500 Angajați
Asistență medicalăConsultanțăMarketing
Summit Therapeutics, Inc. este o companie biofarmaceutică din domeniul oncologiei, care dezvoltă și comercializează medicamente pentru nevoi medicale grave, încă nesatisfăcute. Programul său principal, ivonescimab (SMT112), este un anticorp bispecific care țintește PD-1 și VEGF și este evaluat în studii clinice de fază 3 pentru cancerul pulmonar non-microcelular și alte tumori solide, în baza unei licențe acordate de Akeso. Activitatea companiei acoperă dezvoltarea clinică, strategia de reglementare și potențiala comercializare în teritoriile pentru care deține licență, cu accent pe tratamente concepute pentru a sprijini pacienții și îngrijitorii acestora.
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Locurile de muncă ale companiei

Director of Regulatory Affairs, CMC

Lead global regulatory CMC filings for oncology medicines at Summit Therapeutics. Shape submission strategies and guide Health Authority engagement across clinical and commercial programs.

USStatele Unite ale Americii
190.000 $ – 237.000 $ / an
RemoteNormă întreagăLiderLimbă Obligatorie: englezăConformitate

Descriere

  • Shape CMC regulatory strategy for clinical and commercial development and product lifecycle management
  • Oversee global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements
  • Represent Regulatory CMC on project teams and provide strategic guidance
  • Coordinate with CMC, Supply Chain, Quality, and Regulatory Affairs teams to carry out regulatory strategies
  • Prepare and join Health Authority meeting requests, briefing books, and responses to information requests
  • Assess CMC submission sections for compliance and strategic consistency
  • Lead and contribute to discussions with Health Authorities
  • Set regulatory CMC strategies and assess risks for assigned projects
  • Drive ongoing process improvements with relevant teams and stakeholders
  • Explain global CMC rules and guidance to Summit personnel
  • Assist with Health Authority inspections
  • Raise regulatory compliance concerns with CMC Regulatory Affairs management
  • Keep up to date with global CMC regulations and guidance

Cerințe

  • Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry, or a related science field
  • At least 10 years of Regulatory CMC and/or related pharmaceutical industry experience
  • Experience with biologics
  • Extensive knowledge of FDA, EU, and global regulations
  • Substantial experience setting regulatory strategy for complex products
  • Experience preparing CMC sections for complex regulatory submissions
  • Strong understanding of IND, CTA, BLA, and MAA processes
  • Experience working with Health Authorities on regulatory CMC matters
  • Mandarin proficiency in speaking and writing is highly desirable
  • Microsoft Office, electronic document management system, and document review tool proficiency is desirable
  • Strong computer and database skills
  • Careful, accurate, and discreet handling of information
  • Clear, concise verbal and written communication
  • Strong organizational skills
  • Critical thinking, problem-solving, and ability to work independently
  • Ability to manage multiple tasks and time-sensitive, highly confidential documents
  • Ability to explain complex ideas clearly
  • Ability to prioritize competing demands
  • Ability to work in a fast-paced, demanding, collaborative environment

Beneficii

  • Total compensation may include a bonus, stock, benefits, and/or other applicable variable compensation
  • Equal opportunity employer committed to nondiscrimination in recruitment, hiring, training, and promotion

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