Regulatory Affairs Associate-Annual report / Renewals(Biologics)
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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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