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Senior Regulatory Affairs Associate – Diagnostic Imaging, Interventional Radiology
ParexelSenior Regulatory Affairs Associate managing CMC authoring for medical imaging products. Responsible for regulatory submissions and collaboration with stakeholders in a global setting.
About the role
Key responsibilities & impact- CMC authoring for pharmaceutical products in medical imaging
- Author the CMC part of dossiers and manage worldwide submissions
- Delivery of regulatory submissions and prepare responses to health authority questions
Requirements
What you’ll need- 5 to 8 Years of relevant experience
- Knowledge of regulatory framework in Diagnostic Imaging and Interventional Radiology
- Expertise with regulatory management system and document management systems
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
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Hard Skills & Tools
CMC authoringregulatory submissionsdossier managementdocument management systemsregulatory management system