Senior Regulatory Submissions Specialist

Regulatory Toolkit; Redwood City (CA); On-site; USD 126,000 - 177,000; Full time

Job summary

Corcept Therapeutics, headquartered in Redwood City, CA, is seeking a Senior Associate, Regulatory Operations to support electronic submissions, Veeva Vault maintenance, and SOP development. The role collaborates across departments and vendors to ensure compliant regulatory filings.

The ideal candidate has a BA/BS in a scientific field and 3+ years of pharma regulatory experience, with strong attention to detail and excellent communication skills. This is an on-site, headquarters-based position.

Qualifications

• BA/BS degree in a scientific discipline.
• 3+ years of regulatory experience in the pharmaceutical industry.

Responsibilities

• Compile, format, and publish electronic regulatory submissions to health authorities
• Maintain the Veeva Vault RIM system and keep regulatory records up to date
• Support GxP change control processes in Veeva Vault
• QC regulatory documents prior to submission to health authorities
• Collaborate with external publishing vendors for e-submission files and submission receipts
• Manage tracker with weekly/monthly regulatory submissions and communicate with the Regulatory group
• Maintain templates and style guides for regulatory submissions
• Participate in the development of Standard Operating Procedures (SOPs)
• Support Regulatory team members with regulatory filings and projects, as needed

Skills

Veeva Vault

EU submissions

Detail oriented

Team player

Independent worker

Multi-project mgmt

Time management

MS Office

Education

BA/BS in science

Regulatory experience 3+ years

Job description

Corcept Therapeutics, headquartered in Redwood City, CA, is seeking a Senior Associate, Regulatory Operations to support electronic submissions, Veeva Vault maintenance, and SOP development. The role collaborates across departments and vendors to ensure compliant regulatory filings.

The ideal candidate has a BA/BS in a scientific field and 3+ years of pharma regulatory experience, with strong attention to detail and excellent communication skills. This is an on-site, headquarters-based position.