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Regulatory Affairs Specialist

ComplianceComplianceFull TimeRemoteMid LevelTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

South Korea

Posted

107 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglish

Job Description

Regulatory Affairs Specialist

ICON plc

• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs, with potential involvement in related areas. • Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation. • Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions. • Providing input to the Regulatory Intelligence function and participating in readability testing. • Reviewing IMPD/IB Core Docs and labeling for clinical trials. • Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature. • Facilitating business development activities as needed.

Job Requirements

  • Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
  • Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.
  • Familiarity with label review, translation requirements, and regulatory intelligence activities.
  • Strong attention to detail and excellent communication skills.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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