Associate Director, Regulatory Affairs

Regulatory Toolkit; Redwood City (CA); Ibrido; USD 215.000 - 253.000; Tempo pieno

Descrizione del lavoro

Corcept is seeking an Associate Director to partner with regulatory leadership in obtaining and maintaining regulatory filings for domestic and international regions. The role is hybrid, typically requiring on-site presence three days per week, with responsibilities across strategy, submissions, and cross-functional coordination.

You will lead regulatory document preparation, liaise with FDA and global authorities, and guide teams to ensure compliant, timely submissions while maintaining

Competenze

• Bachelor's degree in life sciences or related field preferred.
• Minimum of 7 years of regulatory experience.
• Experience coordinating with FDA and international health authorities.
• Strong analytical and communication skills.

Mansioni

• Provides team and department leadership.
• Manages the company's interactions with domestic and international health authorities.
• Develops regulatory strategies to support timely approvals and lifecycle management.
• Leads the preparation, review, and submission of regulatory documents for new products and changes.
• Maintains current knowledge of regulatory requirements and translates them into actionable plans.
• Partners with cross-functional teams to advance development programs and regulatory objectives.
• Collaborates with clinical teams to ensure submissions are organized and data-supported.
• Provides guidance and coaching on regulatory projects.
• Oversees regulatory reporting for investigational products.
• Prepares for and follows up on meetings with FDA and other authorities.
• Ensures documentation is inspection-ready and SOPs are maintained.

Conoscenze

Analytical skills

Communication skills

Attention to detail

Project management

Formazione

Bachelor's degree

M.S./Ph.D. in life sciences

Descrizione del lavoro

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

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.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300-$253,200; 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.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.