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Regeneron
Regeneron
Sponzor vizuma H1BBiotehnologijaProizvodnjaZdravstveno varstvo
Regeneron je biotehnološko podjetje, ki odkriva, razvija in trži zdravila za resna in nezadostno obravnavana zdravstvena stanja. Njegove raziskave zajemajo alergije, bolezni srca in ožilja ter presnovne bolezni, nevroznanost, onkologijo, hematologijo, oftalmologijo in redke bolezni. Regeneron s povezovanjem bioloških raziskav in napredne tehnologije razvija biološka in genska zdravila, namenjena reševanju kompleksnih potreb zdravstvenega varstva. Podjetje v okviru svojega širšega poslanstva izboljševanja oskrbe bolnikov poudarja tudi enakost na področju zdravja, okoljsko odgovornost, znanstveno izobraževanje in etične poslovne prakse.
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Delovna mesta v podjetju

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.

USZdružene države AmerikeNJNew Jersey
108.000 $ – 176.000 $ / leto
HibridnoPolni delovni časSrednja ravenSeniorZahtevani Jezik: angleščinaSkladnost

Opis

  • 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

Zahteve

  • 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

Ugodnosti

  • 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

Sorodna delovna mesta

CVS Health

CVS Health Business Compliance Manager, Requests for Information

CVS Health
MaloprodajaZdravstveno varstvoZdravstveno zavarovanje
USZdružene države AmerikeALAlabamaAZArizonaCTConnecticutFLFloridaKSKansasKYKentuckyLALouisianaNJNew JerseyNCSeverna KarolinaOHOhioOKOklahomaPAPensilvanijaRIRhode IslandTNTennesseeTXTeksas
66.330 $ – 145.860 $ / leto
HibridnoPolni delovni časSeniorVodjaZahtevani Jezik: angleščinaSkladnost

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

Odpri