Associate I, Regulatory Affairs

Corcept Therapeutics; Redwood City (CA); Hybride; USD 84 000 - 99 000; Plein temps

Résumé du poste

Corcept Therapeutics, headquartered in Redwood City, CA, seeks an Associate to support Regulatory leadership in developing and executing global regulatory strategies. The role involves preparing submissions, coordinating with CROs, and assisting with health authority interactions.

Candidates typically have 1–2 years of regulatory experience and a Bachelor’s degree in life sciences. The position is hybrid, with on-site days three times per week, offering a competitive pay range and opportunities

Qualifications

• Bachelor’s degree in life sciences required.
• Minimum of 1–2 years of clinical regulatory experience.
• Regulatory submission experience is a plus.

Responsabilités

• Supports Regulatory leadership in development and execution of global nonclinical and clinical regulatory strategies.
• Assists with preparation, review, and submission of regulatory documents.
• Supports health authority interactions, briefing materials, responses, and follow-up documentation.
• Coordinates with CROs and external partners for regulatory submissions and correspondence.
• Collates documents for global regulatory submissions with cross-functional teams.
• Performs quality-control reviews of submission outputs with Regulatory Operations.

Connaissances

Interpersonal skills

Communication skills

Initiative

Prioritization

Team/independent work

Formation

Bachelor’s degree required

Advanced degree preferred

Description du poste

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

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.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $84,400 – $99,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.