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Responsibilities:
- Manage and prepare European CTA submissions and amendments, including master core dossier assembly.
- Provide strategic regulatory advice and support clients in preparing for Scientific Advice meetings.
- QC submissions and maintain eTMF and CTMS systems.
Qualifications:
- Bachelor's degree in life sciences preferred.
- 5+ years EU regulatory experience in pharma or CRO.
- Direct CTIS and IRAS experience required.
Skills:
- Detailed knowledge of ICH-GCP and EU regulations.
- Strong leadership and interpersonal skills.
- Proficiency in Microsoft Office and Veeva/Sharepoint systems.
Theradex Oncology
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.