Regulatory Operations Lead, Veeva Vault & Submissions

Corbus Pharmaceuticals; Norwood (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

A biopharmaceutical firm is seeking a Senior Manager for Regulatory Operations to oversee U.S. regulatory submissions and document management. The ideal candidate will manage Veeva Vault, ensuring organized workflows and compliance in submission preparation. Responsibilities include coordinating submissions, maintaining accurate records of regulatory documents, and supporting continuous process improvement. Candidates should have a Bachelor's degree in life sciences and 5–10 years of relevant experience, particularly with eCTD formats and biopharmaceutical operations.

Qualifications

• 5–10+ years of experience in Regulatory Operations within the biopharmaceutical industry.
• Hands-on experience preparing, formatting, and publishing regulatory submissions in eCTD format.
• Strong understanding of submission components and lifecycle management.

Responsibilities

• Serve as the primary operational lead for Veeva Vault.
• Prepare, format, and compile submission components for U.S. regulatory filings.
• Develop and manage timelines for regulatory deliverables across programs.

Skills

Attention to detail

Document management skills

Organizational skills

Communication and collaboration

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

Job description

A biopharmaceutical firm is seeking a Senior Manager for Regulatory Operations to oversee U.S. regulatory submissions and document management. The ideal candidate will manage Veeva Vault, ensuring organized workflows and compliance in submission preparation. Responsibilities include coordinating submissions, maintaining accurate records of regulatory documents, and supporting continuous process improvement. Candidates should have a Bachelor's degree in life sciences and 5–10 years of relevant experience, particularly with eCTD formats and biopharmaceutical operations.