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Regeneron
Regeneron
H1B vizos rėmėjasBiotechnologijaGamybaSveikatos priežiūra
„Regeneron“ yra biotechnologijų bendrovė, atrandanti, kurianti ir komercializuojanti vaistus sunkioms ir nepakankamai gydomoms ligoms. Jos tyrimai apima alergijas, širdies ir kraujagyslių bei medžiagų apykaitos ligas, neuromokslą, onkologiją, hematologiją, oftalmologiją ir retąsias ligas. Derindama biologinius tyrimus su pažangiomis technologijomis, „Regeneron“ kuria biologinius ir genetinius vaistus, skirtus sudėtingiems sveikatos priežiūros poreikiams spręsti. Siekdama gerinti pacientų priežiūrą, bendrovė taip pat pabrėžia sveikatos lygybę, atsakomybę už aplinką, mokslinį švietimą ir etišką verslo praktiką.
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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.

USJungtinės ValstijosNJNaujasis Džersis
108 000 $ – 176 000 $ / metai
HibridinisVisas etatasVidutinis lygisVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Aprašymas

  • 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

Reikalavimai

  • 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

Privalumai

  • 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

Susiję darbai

CVS Health

CVS Health Business Compliance Manager, Requests for Information

CVS Health
Mažmeninė prekybaSveikatos draudimasSveikatos priežiūra
USJungtinės ValstijosALAlabamaAZArizonaCTKonektikutasFLFloridaKSKanzasasKYKentukisLALuizianaNJNaujasis DžersisNCŠiaurės KarolinaOHOhajasOKOklahomaPAPensilvanijaRIRod AilandasTNTenesisTXTeksasas
66 330 $ – 145 860 $ / metai
HibridinisVisas etatasVyresnysis specialistasVadovasPrivaloma Kalba: anglųAtitiktis

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

Atidaryti
Johnson & Johnson

Director, North America Regulatory Affairs

Johnson & Johnson
H1B vizos rėmėjasBiotechnologijaFarmacijos produktaiSveikatos priežiūra
USJungtinės ValstijosNJNaujasis DžersisPAPensilvanija
164 000 $ – 282 900 $ / metai
HibridinisVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Lead Johnson & Johnson’s regulatory strategy for North American drug development and FDA engagement. Oversee submissions, labeling, health authority interactions, and regulatory teams.

Atidaryti
Johnson & Johnson

Director, North America Regulatory Affairs

Johnson & Johnson
H1B vizos rėmėjasFarmacijos produktaiSveikatos draudimasSveikatos priežiūra
USJungtinės ValstijosNJNaujasis DžersisPAPensilvanija
164 000 $ – 282 900 $ / metai
HibridinisVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Lead Johnson & Johnson’s regulatory strategy for innovative medicines across North America. Oversee FDA and Health Canada submissions, labeling, compliance, and regulatory teams.

Atidaryti