Associate I, Regulatory Affairs

Corcept Therapeutics develops treatments based on cortisol modulation. The Associate supports global nonclinical and clinical regulatory strategies, prepares regulatory submissions, and coordinates health authority interactions with internal teams and external partners.

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

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

Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred

Stakeholder Management

Life Sciences

Chemistry

Molecular Biology

Advanced Degree M.S.

Advanced Degree Pharm.D.

Advanced Degree Ph.D.

Interpersonal Skills

Communication

Initiative

Proactiveness

Adaptability

Problem-Solving

Organization

Multitasking

Time Management

Quality Orientation

Teamwork

Independent Work

Benefits

This is a hybrid role that typically requires on-site presence three days per week.

Company

Develops cortisol modulation therapies for serious diseases.

Redwood City, California, USA

http://www.corcept.com/

Founded in 1998

501-1000 employees

Qualifications

Bachelor's degree required

Minimum of 1-2 years of clinical regulatory experience

Applicants must be currently authorized to work in the United States on a full-time basis

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

Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred

Required skills

Clinical regulatory affairs, Global regulatory submissions, Clinical trial applications, Investigational new drug applications (INDs), New drug applications (NDAs), Marketing authorization applications (MAAs), Health authority interactions

Preferred skills

Strong interpersonal and communication skills

Experience

1-2 years