Regulatory Affairs Associate-Annual report / Renewals(Biologics)
Job Description
Regulatory Affairs Associate
2 to 4 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China.
• Liaise closely with cross-functional members with aligned product responsibilities.
• Knowledge of change evaluation according to country guidelines
• Experience in managing lifecycle activities in the EU markets would be preferrable
• Knowledge of CTD guidelines
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