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Parexel
Parexel
H1B Visa SponsorConsultingHealthcareLogistics
Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
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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.

USUnited StatesRemoteFull-timeSeniorEnglish RequiredCompliance
Vault

Description

  • 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.

Requirements

  • 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).

Benefits

  • 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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