Sr Manager, Corporate Regulatory Affairs - Menlo Park, United States - Corcept Therapeutics

Description

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 Affairs leaders (in each therapy area) to obtain and maintain regulatory filings and registrations for domestic and international regions. The Sr. Manager 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. This position will be onsite in Menlo Park, CA, typically 3 days per week.

Responsibilities:

• 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 the submissions of clinical study submissions
• Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure 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
• Provides guidance with localization and labeling requirements
• Manages regulatory reporting

Preferred Skills, Qualifications and Technical Proficiencies:

• 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
• 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
• High functioning as both a team player and individual contributor

Preferred Education and Experience:

• Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline

The pay range that the Company reasonably expects to pay for this headquarters-based position is $180,000 - $210,000; 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.

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:

Corcept is an Equal Opportunity Employer

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