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Johnson & Johnson
Johnson & Johnson
H1B vizasi homiysiBiotexnologiyaFarmatsevtika mahsulotlariSog‘liqni saqlash
Johnson & Johnson farmatsevtika, tibbiy qurilmalar va iste’molchilar salomatligi yo‘nalishlarida faoliyat yurituvchi global sog‘liqni saqlash kompaniyasidir. Uning tadqiqot va mahsulotlarni ishlab chiqish faoliyati onkologiya, immunologiya, neyrofanlar va kardiopulmonologiya yo‘nalishlaridagi dori vositalari hamda davolash usullarini, shuningdek yurak-qon tomir kasalliklarini davolash, ortopediya, jarrohlik va ko‘rish sohasi uchun MedTech yechimlarini qamrab oladi. Kompaniyaning keng qamrovli faoliyatiga salomatlik va farovonlik bo‘yicha ma’rifiy ishlar, yirik ko‘lamli ishlab chiqarish, investorlar bilan ishlash hamda global ijtimoiy ta’sir tashabbuslari ham kiradi. Bu faoliyatlar ilmiy, klinik, muhandislik, ishlab chiqarish, tijoriy va korporativ funksiyalarda imkoniyatlar yaratadi.
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Kompaniyadagi ish o‘rinlari

Director, North America Regulatory Affairs

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

USAmerika Qo‘shma ShtatlariNJNyu-JersiPAPensilvaniya
164 000 $ – 282 900 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Tavsif

  • Shape and maintain regulatory strategies for North America.
  • Develop and carry out global and North American regulatory strategies.
  • Lead the North American Regulatory Team and guide cross-functional development teams.
  • Align North American work with portfolio priorities.
  • Oversee and critically assess key regulatory submissions.
  • Lead and support engagement with the FDA.
  • Set North American content requirements and timelines for global dossiers, including BLAs, NDAs, INDs, CTAs, addenda, and supplements.
  • Act as the primary contact for the US FDA.
  • Lead teams responding to questions from the FDA and Health Canada.
  • Advise US Business Partners on US regulatory strategies, PMR fulfillment, and other US regulatory matters.
  • Manage routine maintenance submissions and track North American post-approval commitments.
  • Review and approve submission documents before they are sent to regulatory authorities.
  • Contribute to USPI development and lead North American labeling negotiations.
  • Review FDA and Health Canada labeling for consistency with the CCDS.
  • Direct managers and senior individual contributors in a matrixed organization.
  • Hold career development discussions and provide coaching and feedback.
  • Set Regulatory Affairs initiatives that align with corporate strategy and compliance requirements.
  • Work with R&D, Marketing, and other leaders on cross-functional policies and portfolio strategy.
  • Recommend product development approaches in response to expected regulatory changes and emerging issues.
  • Work with stakeholders to shape regulatory policies and positions.
  • Keep management informed about regulatory policies and changes in the regulatory environment.
  • Manage team operations, including budget, performance, compliance, staffing, and succession planning.
  • Build a purpose-driven environment guided by Johnson & Johnson’s Credo and Leadership Imperatives.

Talablar

  • Bachelor’s degree in a scientific or equivalent discipline.
  • At least 10 years of relevant experience.
  • Experience leading interactions with health authorities.
  • Experience with US regulatory affairs.
  • Broad knowledge and experience across drug development, from early and late development through lifecycle management.
  • Ability to interpret regulatory requirements and precedent in scientific and commercial contexts.
  • Working knowledge of US and EMA labeling requirements.
  • In-depth knowledge of current US FDA, Health Canada, and EMA requirements for GRL, as well as global regulations relevant to regulatory strategy.
  • Experience managing a portfolio of multiple products.
  • Ability to lead and contribute as an individual in a matrixed environment.
  • People and project management skills.
  • Strong written and verbal communication skills.
  • Strong organizational and multitasking skills.
  • Independent judgment and ability to resolve complex organizational issues with original solutions.
  • Oncology, cell therapy, or other complex modality experience is preferred.

Imtiyozlar

  • Consolidated pension plan.
  • 401(k) savings plan.
  • Long-term incentive program.
  • 120 vacation hours per calendar year.
  • 40 sick hours per calendar year.
  • 13 days of holiday pay, including floating holidays, per calendar year.
  • Up to 40 hours of work, personal, and family time per calendar year.
  • 480 hours of parental leave within one year of a child’s birth, adoption, or foster placement.
  • Bereavement leave per calendar year: 240 hours for an immediate family member or 40 hours for an extended family member.
  • 80 hours of caregiver leave in a rolling 52-week period.
  • 32 hours of volunteer leave per calendar year.
  • 80 hours of military spouse time off per calendar year.

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