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Responsibilities:
- Develop submission strategies and plans for post-approval CMC activities.
- Review study reports from the quality control and production departments.
- Manage projects within all Regulatory Information Management systems.
Experience and Knowledge Requirements:
- Previous experience in regulatory affairs, particularly related to technical/CMC/quality.
- Strong understanding of CMC and post-approval regulatory requirements.
- Proficiency in Word, PowerPoint, Excel.
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.