Associate Director, Commercial Regulatory Operations

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

Corcept Therapeutics is preparing to launch new products across multiple therapeutic areas in both the U.S. and EU in the coming years. We have an exciting opportunity for a Associate Director, Commercial Regulatory Operations to shepherd the end-to-end review and approval process for promotional and non-promotional materials, ensuring timely, compliant, and efficient execution across cross-functional teams. This role will focus on the logistics and operations of the Content Review Team (CRT), including meeting coordination, material routing, stakeholder engagement, system management, and FDA submission support. The ideal candidate will bring strong organizational skills, familiarity with industry tools, and a collaborative mindset to help drive process excellence, audit readiness, and continuous improvement within a fast-paced, launch-focused environment. This is an excellent opportunity for someone looking to expand their experience in Commercial Regulatory Affairs while contributing to a patient-centered, mission driven company aiming to revolutionize the treatment of serious diseases.

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

Responsibilities:

• Oversee the end-to-end review process for U.S. and Global promotional and non-promotional materials using the document management system (e.g. Veeva)
• Schedule and manage CRT meetings, route materials for review, and track deliverables to ensure timely execution of the process
• Manage and track submission status in Veeva PromoMats and Veeva MedComms to ensure timely review and approval
• Prepare and distribute the weekly CRT agenda, facilitate CRT meetings, and document decisions and comments for team alignment
• Serve as the primary point of contact between cross-functional teams including Regulatory, Legal, Medical, and Commercial to facilitate compliant and consistent review processes
• Partner with Regulatory Operations to ensure timely and accurate FDA Form 2253 submissions
• Maintain and update workflows, review processes, and compliance documentation (e.g., SOPs, charters, guidelines)
• Provide onboarding and training for internal stakeholders on CRT processes, systems, and compliance expectations
• Support issue resolution and escalate matters as needed for decision-making
• Assist with internal audits and inspection readiness efforts related to promotional and non-promotional material review
• Contribute to process improvement initiatives to enhance review efficiency and collaboration
• Prepare regular tracking reports and dashboards summarizing review timelines, volume, and key operational metrics for leadership visibility. Develop, track, and analyze the metrics that access the efficiency and effectiveness of the materials review process, and recommend improvements as needed
• Updating the standard operating procedures (SOPs) related to the material content review and approval process

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience leading or supporting review committee meetings in a pharmaceutical or life sciences setting
• Familiarity with promotional material review processes and product launch support
• Strong interpersonal and cross-functional collaboration skills
• Ability to manage without direct authority and influence stakeholders effectively
• Excellent analytical, problem-solving, and communication skills (written and verbal)
• Proficiency with document and collaboration tools, including Veeva Vault, Box, and SharePoint

Preferred Education and Experience:

• BA/BS Degree in health/life sciences or related field
• 8+ years of experience in the pharmaceutical, life sciences or related industry
• Highly organized, detail-oriented, and adaptable
• Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction
• Ability to synthesize data and derive core insights that inform strategy and processes
• Excellent communicator, both oral and written, with strong presentation skills and able to influence without authority
• Able to work collaboratively in a team environment across various departments and all levels of the organization
• Proven experience leading CRT meetings and navigating cross-functional collaboration
• Exceptional analytical, problem-solving, and written/verbal communication skills
• Demonstrated ability to manage multiple priorities and meet deadlines in a dynamic environment
• Familiarity with regulatory requirements in the pharmaceutical industry

The pay range that the Company reasonably expects to pay for this headquarters-based position is $209,700 - $246,700; 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.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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