Senior Regulatory Affairs Associate – Clinical Trial Application

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

11 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Senior Regulatory Affairs Associate – Clinical Trial Application

Parexel

• Lead end-to-end CTA project management across multiple studies and countries • Plan, track, and deliver submissions aligned with timelines and regulatory requirements • Manage risks, dependencies, and complexities in global regulatory environments • Apply knowledge of EU CTR and ROW CTA requirements • Manage core clinical and regulatory documentation • Collaborate with cross-functional global teams • Build and maintain stakeholder relationships and resolve conflicts • Monitor KPIs related to timelines and deliverable quality • Identify risks and lead quality investigations as needed

Job Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field
  • Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
  • Experience in Clinical Trial Application submissions (EU CTR & ROW)
  • Strong project management experience in a global/matrix environment
  • Familiarity with clinical trials and regulatory processes

Benefits

  • Remote working arrangements
  • Opportunities for professional development

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