Senior Specialist, Regulatory Operations (Fully Remote)

Summit Therapeutics Inc.; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

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

Skills

Regulatory submissions

Veeva RIM

Regulatory operations

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Adobe Acrobat

eCTD

Job description

• Biopharmaceutical oncology company advancing Phase 3 studies in NSCLC and CRC.
• Team driven by integrity, collaboration, and purposeful urgency.

Role:

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

Requirements:

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

Summit Therapeutics Inc.

Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.