Full-Time

Senior Manager

Corporate Regulatory Affairs

Posted on 8/30/2024

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulators for medical conditions

Biotechnology
Healthcare

Compensation Overview

$180k - $210kAnnually

Senior

Menlo Park, CA, USA

Onsite in Menlo Park, CA, typically 3 days per week.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
  • Bachelor’s or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline
  • Strong analytical and problem-solving skills
  • Strong written and verbal communication skills, including the ability to interact effectively and to influence
  • Strong attention to detail
  • Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations
  • High functioning as both a team player and individual contributor
Responsibilities
  • Manages most aspects of company regulatory interface with domestic and international health authorities
  • Manages the development and deployment of the regulatory program that ensures aggressive product approval
  • Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration
  • Manages the submissions of clinical study submissions
  • Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance
  • Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects
  • Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
  • Provides guidance with localization and labeling requirements
  • Manages regulatory reporting

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health conditions. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by excessive cortisol. Korlym was approved by the FDA in 2012 and is the first treatment specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Company Stage

IPO

Total Funding

$39.7M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

3%

1 year growth

2%

2 year growth

-3%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.
  • Advancements in drug delivery systems could enhance Corcept's product efficacy.
  • The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

What critics are saying

  • Teva's antitrust lawsuit could lead to legal expenses and market share loss.
  • Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.
  • Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

What makes Corcept Therapeutics unique

  • Corcept specializes in cortisol modulation, a niche with few direct competitors.
  • Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.
  • Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

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Benefits

Remote Work Options

Flexible Work Hours

INACTIVE