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Parexel
Parexel
H1B वीज़ा प्रायोजकपरामर्शलॉजिस्टिक्सस्वास्थ्य सेवा
Parexel एक वैश्विक क्लिनिकल रिसर्च संगठन है, जो नई दवाओं के विकास के दौरान बायोफार्मास्यूटिकल कंपनियों को सेवाएँ प्रदान करता है। इसका कार्य चरण I–IV क्लिनिकल परीक्षणों, पोर्टफोलियो और परीक्षण प्रबंधन, नियामक रणनीति, बाज़ार तक पहुँच तथा जीवनचक्र योजना तक फैला हुआ है। 21,000 से अधिक पेशेवरों के साथ, Parexel क्लिनिकल, नियामक और उपचार-विज्ञान संबंधी विशेषज्ञता को मरीजों की अंतर्दृष्टि और नवीन परीक्षण डिज़ाइनों के साथ जोड़ता है। कंपनी ऑन्कोलॉजी, न्यूरोसाइंस और दुर्लभ रोगों सहित विभिन्न क्षेत्रों में अनुसंधान का समर्थन करती है और क्लिनिकल विकास को अधिक कुशल तथा मरीज-केंद्रित बनाने पर ध्यान देती है।
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कंपनी की नौकरियाँ

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.

HRक्रोएशियाHUहंगरीPLपोलैंडROरोमानियाRSसर्बियारिमोटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • 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

आवश्यकताएँ

  • 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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