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Regeneron
Regeneron
H1B vizasi homiysiBiotexnologiyaIshlab chiqarishSog‘liqni saqlash
Regeneron jiddiy va tibbiy ehtiyojlari yetarlicha qondirilmagan kasalliklarga qarshi dori vositalarini kashf etadigan, ishlab chiqadigan va tijoratlashtiradigan biotexnologiya kompaniyasidir. Uning tadqiqotlari allergiya, yurak-qon tomir va metabolik kasalliklar, neyrofan, onkologiya, gematologiya, oftalmologiya hamda kam uchraydigan kasalliklarni qamrab oladi. Regeneron biologik tadqiqotlarni ilg‘or texnologiyalar bilan birlashtirib, murakkab tibbiy ehtiyojlarni qondirishga mo‘ljallangan biologik preparatlar va genetik dori vositalari ustida ishlaydi. Kompaniya bemorlarga ko‘rsatiladigan yordamni rivojlantirishga qaratilgan kengroq missiyasining bir qismi sifatida sog‘liqni saqlashdagi tenglik, atrof-muhitga mas’uliyat, ilmiy ta’lim va axloqiy korporativ amaliyotlarni ham ta’kidlaydi.
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Kompaniyadagi ish o‘rinlari

CMC Regulatory Affairs Manager — Regeneron (Hybrid)

Manage CMC regulatory strategy for biologics at Regeneron, supporting development, submissions, and compliance. Coordinate global strategies and health authority interactions for medicines.

USAmerika Qo‘shma ShtatlariNJNyu-Jersi
108 000 $ – 176 000 $ / yil
GibridTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Tavsif

  • Lead CMC regulatory strategies for assigned biologic products
  • Support CMC development from early stages through submissions and post-market activities
  • Evaluate changes and deviations for regulatory impact and filing needs
  • Review regulatory submissions for alignment with applicable regulations and guidance
  • Assist with health authority engagement, including meetings and responses to information requests
  • Create work instructions, SOPs, and reviewer guides to promote consistent practices
  • Spot regulatory process gaps and propose ways to improve efficiency
  • Turn unclear issues into practical next steps and build agreement across teams
  • Work with Global Regulatory Affairs and CMC partners
  • Contribute to training and help address technical or regulatory knowledge gaps

Talablar

  • Bachelor’s degree plus at least 6 years of experience, or an advanced degree plus at least 3 years, in pharmaceutical, biotechnology, or health authority settings
  • 2–4 years of CMC Regulatory Affairs experience involving regulations worldwide
  • Strong knowledge of global CMC Regulatory Affairs requirements
  • Experience preparing CMC sections for marketing authorizations, CTA/INDs, and post-approval submissions
  • Experience supporting biologic products is preferred
  • Experience working with the FDA or other regulatory authorities is preferred
  • Strong communication, negotiation, strategic thinking, and problem-solving abilities
  • Ability to build cross-functional partnerships, balance competing priorities, and deliver results in changing environments
  • Ability to contribute to training and proactively address technical or regulatory knowledge gaps
  • Background screening may include identity, work authorization, and education verification

Imtiyozlar

  • Annual bonuses or other incentive programs
  • Equity awards
  • Pension or retirement benefits
  • Company matching contributions to a 401(k)
  • Health and wellness programs
  • On-site fitness centers
  • Medical, dental, vision, life, and disability insurance
  • Paid leave
  • Family support programs
  • Reasonable accommodations during recruitment where required

O‘xshash ish o‘rinlari

CVS Health

CVS Health Business Compliance Manager, Requests for Information

CVS Health
Chakana savdoSog‘liqni saqlashTibbiy sug‘urta
USAmerika Qo‘shma ShtatlariALAlabamaAZArizonaCTKonnektikutFLFloridaKSKanzasKYKentukkiLALuizianaNJNyu-JersiNCShimoliy KarolinaOHOgayoOKOklaxomaPAPensilvaniyaRIRod-AylendTNTennessiTXTexas
66 330 $ – 145 860 $ / yil
GibridTo‘liq stavkaSeniorYetakchiTalab Qilinadigan Til: inglizchaMuvofiqlik

Oversee regulatory information requests across CVS Health operations and jurisdictions. Lead analysts and coordinate compliant responses with Legal, Compliance, and Operations.

Ochish