Full-Time

Sr Associate

Regulatory Operations

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

501-1,000 employees

Develops cortisol modulators for medical conditions

Compensation Overview

$121.3k - $142.8k/yr

Mid, Senior

San Carlos, CA, USA

This is a hybrid role typically requiring on-site presence at least 3 days per week.

Category
Risk & Compliance
Contract Management
Legal & Compliance
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
  • Detail oriented with excellent oral and written communication skills
  • Strong team player, self-motivated and able to function independently as well as part of a team
  • Able to work on multiple projects concurrently and adapt to a continuously changing environment
  • Proficient in organization, prioritization, and time management
  • Experience with Microsoft Word, PowerPoint and Excel
  • BA/BS degree in a scientific discipline
  • 3+ years of relevant regulatory experience in the pharmaceutical industry
Responsibilities
  • Assisting Regulatory Operations members with maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date
  • Supporting the GxP change control processes in Veeva Vault
  • Supporting the QC of regulatory documents prior to submission to health authorities
  • Collaborate with the publishing vendor for e-submission files and submission receipts
  • Managing the spreadsheet with all weekly/monthly regulatory submissions and communicating the information with the publishing vendor
  • Maintaining templates and style guides for regulatory submissions
  • Supporting regulatory contract finalization through Corcept’s online contract management platform
  • Participating in the development of Standard Operating Procedures (SOPs)
  • Managing the preparation and submission of IND/NDA annual reports to health authorities
  • Supporting Regulatory team members with regulatory filings and projects, as needed
Desired Qualifications
  • Experience with publishing and Veeva Vault systems is preferred

Corcept Therapeutics develops cortisol modulators to help regulate cortisol levels in the body, focusing on treatments for conditions like Cushing's syndrome, which is caused by excessive cortisol. Their main product, Korlym (mifepristone), is the first FDA-approved treatment for hypercortisolism in Cushing's syndrome patients. Corcept distinguishes itself from competitors by investing heavily in research and development of proprietary molecules and by supporting medical education for healthcare professionals and patients. The company's goal is to lead in cortisol modulation and improve treatment options for patients with cortisol-related disorders.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Menlo Park, California

Founded

1998

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased interest in cortisol modulation for mental health expands market opportunities.
  • Advancements in drug delivery systems could enhance efficacy of cortisol modulators.
  • Growing trend of personalized medicine benefits Corcept's targeted cortisol modulators.

What critics are saying

  • Ongoing securities fraud investigations could impact investor confidence and stock value.
  • Mixed results from Phase II ALS trial may affect dazucorilant's future development.
  • Competitive landscape in biopharmaceuticals may threaten Corcept's market share.

What makes Corcept Therapeutics unique

  • Corcept specializes in cortisol modulation, a niche area in biopharmaceuticals.
  • Korlym is the first FDA-approved treatment for Cushing's syndrome.
  • Corcept has discovered over 1,000 selective cortisol modulators.

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Benefits

Remote Work Options

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

-1%

1 year growth

1%

2 year growth

-3%
BioSpace
Jun 10th, 2025
Corcept Claims Survival Benefit In Als Despite Missed Endpoint

Corcept Therapeutics ’ investigational cortisol modulator dazucorilant failed to boost functional performance in patients with amyotrophic lateral sclerosis—but the biotech dug into the data Thursday and came away with overall survival benefits.Analysts at Truist Securities called the Phase II readout a “mixed bag” in an investor note on Thursday, adding that aside from the missed primary endpoint, dazucorilant also elicited “increased” gastrointestinal adverse events. “We would have liked to see some QoL [quality of life] assessments to better gauge commercial potential as discontinuation rates” seemed higher in the dazucorilant group versus placebo, they said.Still, Truist considered Thursday’s readout to be only “incremental” to Corcept’s overall stock narrative. The analyst firm does not include dazucorilant in its valuation for the biotech.Thursday’s data, presented at the 2025 annual meeting of the European Network to Cure ALS, showed no statistical separation between dazucorilant and placebo patients in terms of scores on the ALS Functional Rating Scale-Revised , a disease-specific severity score that evaluates patients’ disability and respiratory function, among other metrics.However, an exploratory analysis found that dazucorilant treatment significantly improved overall survival. At 24 weeks, five of 82 patients on placebo died, as opposed none of the 83 patients in the dazucorilant arm. At one year, treatment with dazucorilant cut the risk of death by 84% versus placebo. The biotech called this effect “pronounced” in its Thursday release.Given the mixed mid-stage findings, Corcept is currently “working with regulatory authorities” to determine the best path forward for dazucorilant, Bill Guyer, the company’s chief development officer, said in a prepared statement on Thursday.The ALS readout comes after Corcept earlier this week unveiled Phase III data for its selective glucocorticoid receptor antagonist relacorilant, which it combined with nab-paclitaxel to treat patients with platinum-resistant ovarian cancer.The findings, revealed in a late-breaking presentation at the recently concluded 2025 conference of the American Society of Clinical Oncology, showed that the relacorilant regimen cut the risk of disease progression by 30% versus nab-paclitaxel alone

Fierce Biotech
Jun 5th, 2025
Corcept unveils promising survival data from failed phase 2 ALS trial

In a presentation at the European Network to Cure ALS 2025 annual meeting this week, Corcept included a table showing that the decline as measured by a functionality scale was broadly the same across both dazucorilant cohorts and the placebo group over 24 weeks.

Business Wire
Apr 23rd, 2025
CORCEPT TO PRESENT LATE-BREAKING DATA FROM PIVOTAL PHASE 3 ROSELLA TRIAL OF RELACORILANT IN PLATINUM-RESISTANT OVARIAN CANCER AT ASCO 2025

CORCEPT to present late-breaking data from pivotal Phase 3 ROSELLA trial of Relacorilant in platinum-resistant Ovarian Cancer at ASCO 2025.

Access News Wire
Mar 18th, 2025
Shareholders that lost money on Corcept Therapeutics Incorporated(CORT) should contact Levi & Korsinsky about Securities Fraud Investigation - CORT

NEW YORK, NY / ACCESS Newswire / March 18, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Corcept Therapeutics Incorporated ("Corcept Therapeutics Incorporated") (NASDAQ:CORT) concerning possible violations of federal securities laws.

Stock Titan
Mar 10th, 2025
Corcept Therapeutics Initiates MOMENTUM Trial to Determine Prevalence of Hypercortisolism in Patients with Resistant Hypertension

Corcept Therapeutics (NASDAQ: CORT) has launched the MOMENTUM clinical trial to investigate the prevalence of endogenous hypercortisolism (Cushing's syndrome) in patients with resistant hypertension.