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Parexel
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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 Associate, Regulatory Compliance — Parexel Remote

Senior Regulatory Affairs Associate supporting Parexel’s global regulatory compliance operations remotely in the United States. The role covers SOP governance, inspection readiness, regulatory metrics, and cross-functional compliance coordination.

USसंयुक्त राज्यरिमोटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन
Vault

विवरण

  • Coordinate Global Regulatory Affairs SOP revision cycles, including controlled documents and ad hoc updates.
  • Schedule kickoff meetings, manage timelines, support document revisions, and update the GRA SOP tracker.
  • Maintain working knowledge of and access to GSOP platforms, including Veeva Vault and Monday.com.
  • Support inspection readiness through calendar management, presentations, notifications, document requests, audit reports, CAPAs, and deviations.
  • Partner with Regulatory Intelligence and Pharmacovigilance teams to update the annual Regulatory Requirements Summary.
  • Review and qualify notifications from the curated Pharmacovigilance dashboard inbox.
  • Create and distribute newsletters and compliance communications.
  • Coordinate monthly regulatory milestone reporting with Regulatory Strategy.
  • Organize and facilitate GRA staff, steering group, and departmental meetings.
  • Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts.
  • Prepare KPI reports, including training metrics, and publish results on the GRA Collaboration Portal.
  • Develop and maintain compliance work instructions, SOP revisions, milestone reviews, and onboarding and offboarding materials.
  • Provide meeting and project support, including reports, presentations, agendas, minutes, and deliverable follow-up.
  • Keep activities on schedule and escalate challenges or deviations.
  • Track compliance performance metrics and produce status reports for management and project teams.
  • Contribute to continuous improvement initiatives.
  • Create, administer, and summarize surveys.

आवश्यकताएँ

  • Bachelor’s degree in a life sciences, scientific, or engineering discipline.
  • At least three years of general regulatory affairs experience and knowledge of pharmaceutical drug development.
  • Three years of audit and inspection exposure or experience.
  • Strong written and verbal communication skills.
  • Working knowledge of the drug development process, laws, regulations, and guidelines, including FDA, ICH, and other regulatory requirements.
  • Experience in regulatory affairs, healthcare, or another regulated environment.
  • Experience using document management systems and regulatory compliance tools.
  • Demonstrated proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Ability to prioritize tasks, multitask, solve problems, and perform effectively in a fast-paced environment.
  • Preferred: Experience with new prescription drug or biologic applications, including IND and/or NDA/BLA submissions.
  • Preferred: Familiarity with electronic document management systems (EDMS).

लाभ

  • Health, vision, and dental insurance.
  • Tuition reimbursement.
  • Vacation, holiday, and sick time.
  • Flexible spending and health savings accounts.
  • Work-life balance support.
  • 401(k) plan with company match.
  • Pet insurance.
  • Paid time off.
  • Life insurance.
  • Additional benefits provided under applicable plans.
  • Some roles may qualify for additional incentives, bonuses, or other compensation programs.

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