Associate Director, Regulatory Affairs

Menlo Park, CA, United States

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 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 advance 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.

This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. This Associate Director will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions.

Responsibilities:

Provide team and department leadership

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 and/or oversees project-related nonclinical and clinical submissions

Maintain up-to-date knowledge of regulatory requirements. Disseminates information regarding governmental regulations and guidances that may affect company processes. Provide expertise in translating regulatory requirements into practicable, workable plans and follows up, as applicable, to assure awareness for 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

Determines international regulatory requirements and develops plans to comply with national laws in each country

Provides guidance with localization and labeling requirements

Manages regulatory reporting requirements for investigational products

Provide support for meetings with FDA/health authorities

Help maintain regulatory files

Support the timely preparation of organized and scientifically valid applications to Health authorities

Contribute to the development and implementation of standard operating procedures (SOPs) and policies

Preferred Skills, Qualifications and Technical Proficiencies:

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.

Preferred Education and Experience:

Bachelors or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline.

Minimum of 5 years of relevant regulatory experience.

The pay range that the Company reasonably expects to pay for this headquarters-based position is $204,000-$240,000; 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.

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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.

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