Senior Regulatory Submissions Specialist — eCTD & FDA/ICH

Summit Therapeutics Inc.; United States; Remote; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Summit Therapeutics Inc. in the United States is seeking a Regulatory Operations professional to manage end-to-end eCTD submissions and regulatory records.

You will publish, QC, and track submissions to health authorities, while maintaining Veeva RIM systems and supporting cross-functional teams. The ideal candidate has a life sciences degree with 4+ years of Regulatory Operations experience, strong expertise in FDA/ICH standards, and proficiency in Word, Acrobat, and eCTD processes.

Qualifikationen

• Bachelor's in life sciences with 4+ years Regulatory Operations experience.
• Strong Word, Adobe Acrobat, eCTD, and FDA/ICH standards expertise.

Aufgaben

• Prepare, publish, and QC eCTD regulatory submissions to health authorities.
• Maintain Veeva RIM records and support submission projects.

Kenntnisse

Regulatory submissions

Veeva RIM

Regulatory operations

Ausbildung

Bachelor's degree in life sciences

Tools

Microsoft Word

Adobe Acrobat

eCTD

Jobbeschreibung

Summit Therapeutics Inc. in the United States is seeking a Regulatory Operations professional to manage end-to-end eCTD submissions and regulatory records.

You will publish, QC, and track submissions to health authorities, while maintaining Veeva RIM systems and supporting cross-functional teams. The ideal candidate has a life sciences degree with 4+ years of Regulatory Operations experience, strong expertise in FDA/ICH standards, and proficiency in Word, Acrobat, and eCTD processes.