Senior Regulatory Submissions Specialist

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

Job summary

Corcept Therapeutics is seeking a Senior Associate, Regulatory Operations to support regulatory submissions and maintain Veeva Vault records. You will collaborate with cross‑functional teams and vendors to ensure timely, compliant filings.

A BA/BS in a scientific discipline and 3+ years of pharma regulatory experience are preferred. This headquarters‑based role requires meticulous attention to detail, strong communication skills, and the ability to manage multiple projects in a fast‑paced

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.
• Support Regulatory Operations in maintaining Veeva Vault RIM system and ensure regulatory records are up to date.
• Support GxP change control processes in Veeva Vault.
• Assist in QC of 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 Regulatory group.
• Maintain templates and style guides for regulatory submissions.
• Participate in development of SOPs.
• Support regulatory filings and projects as needed.

Skills

Veeva Vault

EU submissions

Attention to detail

Oral and written communication

Team player

Multi‑project management

Time management

Microsoft Word/PowerPoint/Excel

Education

BA/BS in a scientific discipline

3+ years regulatory experience in pharma

Tools

Veeva Vault

Microsoft Word

PowerPoint

Excel

Job description

Corcept Therapeutics is seeking a Senior Associate, Regulatory Operations to support regulatory submissions and maintain Veeva Vault records. You will collaborate with cross‑functional teams and vendors to ensure timely, compliant filings.

A BA/BS in a scientific discipline and 3+ years of pharma regulatory experience are preferred. This headquarters‑based role requires meticulous attention to detail, strong communication skills, and the ability to manage multiple projects in a fast‑paced