Associate I, Regulatory Affairs
Corcept Therapeutics
Summary
The Associate supports Regulatory leadership in development and execution of global nonclinical and clinical regulatory strategies, preparing for health authority interactions and supporting regulatory submissions. The Associate works with internal cross functional study team members and external parties (e.g., health authorities, vendors, and consultants) to maintain up-to-date information on regulatory requirements and submissions.
Job description
This is a hybrid role that typically requires on-site presence three days per week.
Responsibilities
- Participates in cross-functional teams supporting clinical studies to develop Corcept products
- Assists with the preparation, review, and submission of regulatory documents
- Supports preparation for health authority interactions and meetings, including briefing materials, responses, and follow-up documentation
- Coordinates with clinical research organizations and other external partners supporting global regulatory submissions and health authority correspondence
- Collaborates with nonclinical, clinical, and other cross-functional teams to collect and compile documents for global regulatory submissions
- Collaborates with Regulatory Operations to provide final documents and performs quality-control reviews of published submission outputs
- Supports the submission and maintenance of investigational new drug applications and clinical trial applications
- Supports the maintenance of marketed product applications (i.e., NDAs and MAAs)
- Supports regulatory reporting requirements for investigational and marketed products
- Tracks regulatory submission timelines, deliverables, and health authority commitments
- Maintains current knowledge of applicable regulatory requirements and performs assigned activities in accordance with company procedures and applicable regulations
Preferred Skills, Qualifications and Technical Proficiencies
- Strong interpersonal and communication skills
- Demonstrates initiative and proactively supports project and team needs
- Adapts to changing priorities and contributes to practical, solution-oriented problem-solving
- Ability to organize and manage multiple assignments from different stakeholders while meeting established timelines and quality expectations
- Ability to work effectively both as a collaborative team member and as an individual contributor, with appropriate guidance
Preferred Education and Experience
- Bachelor’s degree required. Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred
- Minimum of 1-2 years of clinical regulatory experience
Requirements
- Bachelor’s degree required
- Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences preferred
- Minimum of 1-2 years of clinical regulatory experience
- Strong interpersonal and communication skills
- Demonstrates initiative and proactively supports project and team needs
- Adapts to changing priorities and contributes to practical, solution-oriented problem-solving
- Ability to organize and manage multiple assignments from different stakeholders while meeting established timelines and quality expectations
- Ability to work effectively both as a collaborative team member and as an individual contributor, with appropriate guidance
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.