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Biogen
Biogen
5 001 – 10 000 Xodimlar
H1B vizasi homiysiBiotexnologiyaIshlab chiqarishSog‘liqni saqlash
Biogen jiddiy nevrologik kasalliklarga qarshi davolash usullarini tadqiq etish, ishlab chiqish va taqdim etishga yo‘naltirilgan biotexnologiya va sog‘liqni saqlash kompaniyasidir. Kompaniyaning faoliyati Altsgeymer kasalligi, ko‘p skleroz va spinal mushak atrofiyasi kabi kasalliklarni qamrab oladi; nevrologiyani rivojlantirish uchun klinik tadqiqotlar, ilmiy hamkorlik va dori vositalarini ishlab chiqishni birlashtiradi. Kompaniya, shuningdek, tibbiy yordamdan foydalanish imkoniyatlarini yaxshilash va sog‘liqni saqlashda yanada katta tenglikni qo‘llab-quvvatlashga e’tibor qaratadi.
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Kompaniyadagi ish o‘rinlari

Senior Manager, Global Regulatory Affairs at Biogen

Support regulatory strategy and submissions for Biogen’s biotechnology programs, including IND, CTA, NDA, and BLA filings. Coordinate health authority responses, labeling, and submission execution with global and cross-functional teams.

USAmerika Qo‘shma ShtatlariCAKaliforniya
140 000 $ – 187 250 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik
Vault

Tavsif

  • Partner with the Global Regulatory Lead on strategy and execution for assigned programs.
  • Contribute regulatory input to cross-functional teams and align submission plans with labeling strategy.
  • Lead or support reviews of IND, CTA, NDA, BLA, and supplemental submission packages.
  • Manage health authority inquiries and deliver timely, accurate responses through resolution.
  • Coordinate submission logistics and document delivery with Regulatory Operations and CROs.
  • Advise on US labeling precedence and help implement US labeling across functions.
  • Update regulatory systems such as GRIT to track submission approvals related to supply release.
  • Provide backup coverage for regulatory colleagues to maintain continuity of support.

Talablar

  • Bachelor’s degree and at least five years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
  • Strong grasp of global regulatory requirements, including the ability to interpret regulations, guidelines, and policy statements.
  • Experience managing regulatory submissions across regions and formats, including INDs, CTAs, and NDAs or BLAs.
  • Strong planning, organization, and project management capabilities.
  • Clear written and verbal communication skills for explaining regulatory topics and updates to cross-functional teams.
  • Ability to build effective cross-functional relationships and contribute to creative problem-solving.
  • Experience with regulatory platforms and tools such as Veeva Vault, Docubridge, and CTIS.
  • Able to work independently and reliably in a fast-paced, matrixed team environment.

Imtiyozlar

  • Eligible regular employees may receive short- and long-term incentives, including cash bonuses and equity awards.
  • Medical, dental, vision, and life insurance coverage.
  • Fitness and wellness programs, including fitness reimbursement.
  • Short- and long-term disability insurance.
  • At least 15 days of paid vacation, plus year-end shutdown leave from December 26 through December 31.
  • Up to 12 company-paid holidays and three paid days off for Personal Significance.
  • 80 hours of sick leave per calendar year.
  • Paid maternity and parental leave.
  • 401(k) plan with company matching contributions.
  • Employee stock purchase plan.
  • Tuition reimbursement up to $10,000 per calendar year.
  • Access to employee resource groups.

O‘xshash ish o‘rinlari

Erasca, Inc.

Senior Manager or Associate Director, Regulatory Operations

Erasca, Inc.
51 – 200 Xodimlar
BiotexnologiyaFarmatsevtika mahsulotlariSog‘liqni saqlash
USAmerika Qo‘shma ShtatlariCAKaliforniya
185 000 $ – 200 000 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Lead regulatory operations and submissions at Erasca, a clinical-stage precision oncology company. Oversee regulatory systems, documentation, health authority correspondence, and cross-functional submission delivery.

Ochish
Environmental Science Associates

Senior Environmental Compliance Specialist – Nevada Energy Infrastructure

Environmental Science Associates
501 – 1 000 Xodimlar
Konsalting
USAmerika Qo‘shma ShtatlariAZArizonaCAKaliforniyaNVNevada
80 000 $ – 105 000 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Lead construction compliance, permitting, and regulatory coordination for energy infrastructure projects across the Southwest. The role oversees field teams and agency relationships in California, Nevada, and Arizona.

Ochish
ERM

Senior Associate, Environmental Health and Safety Compliance

ERM
5 001 – 10 000 Xodimlar
H1B vizasi homiysiIshlab chiqarishLogistikaSog‘liqni saqlash
USAmerika Qo‘shma ShtatlariCAKaliforniya
71 800 $ – 90 500 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Deliver EHS compliance consulting through audits, risk assessments, and corrective actions for ERM clients across Southern California. Support industrial, technology, healthcare, and other sectors with safety and sustainability projects.

Ochish
ERM

Senior Associate, EHS Compliance Consultant

ERM
5 001 – 10 000 Xodimlar
H1B vizasi homiysiIshlab chiqarishLogistikaSog‘liqni saqlash
USAmerika Qo‘shma ShtatlariCAKaliforniya
71 800 $ – 90 500 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Deliver EHS compliance consulting, audits, risk assessments, and sustainability work for ERM clients across Southern California. Support industrial, technology, healthcare, and other global clients on regulatory and safety programs.

Ochish