Associate Director, Regulatory Affairs

Corcept Therapeutics•Redwood City, CA

1d•$215,300 - $253,200•Hybrid

About The Position

The Associate Director, Regulatory Affairs partners with regulatory leadership to obtain and maintain regulatory filings and registrations for domestic and international regions. The role coordinates with internal team members and external parties, including regulatory bodies, vendors, and consultants, to keep regulatory requirements and product submissions up to date. This is a hybrid role that typically requires on-site presence three days per week. The position is based at Corcept’s headquarters in Redwood City, California.

Requirements

Bachelor’s degree.
Minimum of 7 years of relevant regulatory experience.
Strong analytical and problem-solving skills.
Strong written and verbal communication skills, including the ability to interact effectively and influence.
Strong attention to detail.
Ability to balance and manage multiple projects from multiple stakeholders in a timely and quality manner.
Must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

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

Responsibilities

Provides team and department leadership.
Manages the company’s interactions with domestic and international health authorities.
Develops and executes regulatory strategies to support timely approval and lifecycle management of company products.
Leads the preparation, review, and submission of regulatory documents for new products and changes to existing applications, including domestic and international submissions and registrations.
Maintains current knowledge of applicable U.S. and international regulatory requirements, guidelines, and emerging developments; translates these into practical plans and supports organizational awareness and compliance.
Partners cross-functionally with Clinical Operations, Clinical Development, Quality, and other functions to advance development programs and regulatory objectives.
Collaborates with clinical teams to ensure regulatory submissions and clinical presentations are appropriately organized, accurate, complete, and supported by relevant data.
Provides guidance, coaching, and subject-matter expertise to colleagues supporting assigned projects.
Oversees regulatory reporting requirements for investigational products.
Manages preparation for, participation in, and follow-up to meetings with FDA and other global health authorities.
Ensures regulatory documentation and files are complete, accurate, current, and inspection-ready.
Contributes to the development, implementation, and maintenance of regulatory standard operating procedures, policies, and processes.