Senior Regulatory Affairs Associate (FDA expertise)
Parexel(2 months ago)
About this role
Parexel is hiring a Senior Regulatory Affairs Associate to support a major dedicated client partnership, contributing to therapies that improve patient health. The role serves as a key regulatory contact with local health authorities and internal stakeholders to support product launches and ongoing product maintenance. This position operates in a fast-changing environment and focuses on ensuring regulatory alignment at the local/affiliate level.
Required Skills
- Regulatory Affairs
- FDA Regulations
- Health Authority Liaison
- Regulatory Submissions
- Dossier Preparation
- Lifecycle Management
- Labeling Updates
- CMC Changes
- PSURs
- Veeva Vault RIMS
+10 more
Qualifications
- Bachelor’s Degree (Natural Sciences)
- Master’s Degree
- PhD
- RAC
- CARP
- CHPC
About Parexel
parexel.comFor over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.
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