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Parexel
Parexel
H1B vizasi homiysiKonsaltingLogistikaSog‘liqni saqlash
Parexel yangi dori vositalarini ishlab chiqish jarayonida biofarmatsevtika kompaniyalariga xizmat ko‘rsatuvchi global klinik tadqiqot tashkilotidir. Uning faoliyati I–IV bosqich klinik sinovlari, portfel va tadqiqotlarni boshqarish, tartibga solish strategiyasi, bozorga chiqish hamda hayotiy siklni rejalashtirishni qamrab oladi. 21 000 dan ortiq mutaxassisga ega Parexel klinik, tartibga solish va terapevtik tajribani bemorlar haqidagi tushunchalar hamda innovatsion sinov dizaynlari bilan birlashtiradi. Kompaniya onkologiya, neyrofanlar va kam uchraydigan kasalliklar kabi yo‘nalishlarda tadqiqotlarni qo‘llab-quvvatlaydi hamda klinik ishlab chiqish jarayonini samaraliroq va bemorga yo‘naltirilgan qilishga e’tibor qaratadi.
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Kompaniyadagi ish o‘rinlari

Senior Regulatory Affairs Consultant, EU Regulatory Strategy (MAA)

Support EU medicine approvals, EMA engagement, and product lifecycle strategies as a Senior Regulatory Affairs Consultant at Parexel. Lead marketing authorisation applications, regulatory dossiers, and health-authority submissions across five European countries.

HRXorvatiyaHUVengriyaPLPolshaRORuminiyaRSSerbiyaMasofaviyTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Tavsif

  • Lead Marketing Authorisation Applications (MAAs), advising on regulatory pathways and dossier strategy
  • Create and implement regulatory strategies aligned with development timelines and commercial goals
  • Review critical documents and deliver competitive regulatory intelligence for decision-making
  • Prepare briefing books, paediatric development plans, and scientific advice materials
  • Own Module 1 documentation and coordinate submission preparation
  • Provide timely, high-quality responses to health-authority questions and requests
  • Deliver regulatory activities on schedule across assigned products and programmes
  • Lead EMA pre-submission work, scientific advice procedures, and post-approval maintenance
  • Coordinate with health authorities and Clinical, Medical, Safety, Quality, CMC, and Commercial stakeholders
  • Advise senior stakeholders and resolve complex regulatory issues in a consulting environment

Talablar

  • A university degree in a life science discipline
  • Substantial Regulatory Affairs experience supporting EU product development and lifecycle management
  • Demonstrated experience leading or supporting EMA interactions and regulatory procedures
  • Strong knowledge of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements
  • Experience preparing and reviewing regulatory documents, including Module 1 content and health-authority briefing materials
  • Proven capability in regulatory strategy, dossier review, and health-authority engagement
  • Strong project leadership, stakeholder management, and communication skills
  • Ability to manage competing regulatory priorities while maintaining high-quality delivery in a fast-paced setting
  • Fluent written and spoken English

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