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Regulatory Affairs Associate – Annual Report / Renewals, Biologics
Location
India
Posted
64 days ago
Salary
0
Seniority
Mid Level
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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