Associate Director, Regulatory Affairs
Corcept Therapeutics
Summary
The Associate Director partners with regulatory leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. The 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.
Job description
This is a hybrid role that typically requires on-site presence three days per week.
Responsibilities
- Provides team and department leadership
- Manages the company’s interactions with domestic and international health authorities
- Develops and executes regulatory strategies to support the 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 regulatory requirements into practical, actionable plans and follows through to support 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 that 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 the preparation for, participation in, and follow-up to meetings with FDA and other global health authorities
- Ensures that 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
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
- Ability to balance and manage multiple projects from multiple stakeholders in a timely and quality manner
Preferred Education and Experience
- Bachelor’s degree. Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred
- Minimum of 7 years of relevant regulatory experience
Requirements
- Bachelor’s degree
- Minimum of 7 years of relevant regulatory experience
- Strong analytical and problem-solving skills
- Strong written and verbal communication skills
- Strong attention to detail
- Ability to balance and manage multiple projects
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.