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Regulatory Affairs Associate – Annual Report / Renewals, Biologics

ComplianceComplianceFull TimeRemoteMid LevelTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

64 days ago

Salary

0

Seniority

Mid Level

2 yrs expEnglish

Job Description

Regulatory Affairs Associate – Annual Report / Renewals, Biologics

Parexel

• Understand the regulatory framework and regional trends for various types of applications • Support Annual reports/Renewals in multiple regions • Liaise with cross-functional members with aligned product responsibilities • Evaluate changes according to country guidelines • Manage lifecycle activities in the EU markets

Job Requirements

  • 2 to 4 years of experience in Regulatory Affairs-CMC
  • Willingness to work in EU Shifts
  • Knowledge of regulatory framework for applications and procedures for small and large molecules
  • Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China
  • Liaise closely with cross-functional members
  • Knowledge of change evaluation according to country guidelines
  • Experience in managing lifecycle activities in the EU markets
  • Knowledge of CTD guidelines

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