IND Application
An IND Application (Investigational New Drug Application) is a formal request to the FDA to start testing a new drug in humans. Think of it as a permission slip that pharmaceutical companies need before they can begin clinical trials. It contains all the early research data about the drug, including lab tests and animal studies, to show that it might be safe to try in people. This is a crucial first step in getting a new medicine approved, similar to submitting building plans before starting construction. When you see this term in resumes, it usually means the person has experience in preparing or managing these important regulatory submissions.
Examples in Resumes
Managed preparation and submission of IND Application for novel cancer therapy
Led cross-functional team in developing IND documentation for Phase 1 clinical trial
Successfully submitted 5 INDs to FDA with 100% acceptance rate
Typical job title: "Regulatory Affairs Specialists"
Also try searching for:
Where to Find Regulatory Affairs Specialists
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: Can you explain your strategy for managing a challenging IND submission?
Expected Answer: Should discuss experience leading teams, handling timeline pressures, coordinating with different departments (clinical, manufacturing, safety), and maintaining communication with FDA. Should mention risk management and problem-solving examples.
Q: How do you stay current with FDA guidance changes that might affect IND submissions?
Expected Answer: Should explain methods for tracking regulatory updates, involvement in professional organizations, and experience implementing new requirements into submission processes.
Mid Level Questions
Q: What are the key components of an IND application?
Expected Answer: Should be able to explain the main sections: preclinical data, manufacturing information, clinical protocols, and investigator information, in non-technical terms.
Q: How do you ensure quality control in IND documentation?
Expected Answer: Should discuss review processes, quality checks, ensuring consistency across documents, and experience with document management systems.
Junior Level Questions
Q: What is the purpose of an IND application?
Expected Answer: Should explain that it's the formal request to FDA to begin testing a new drug in humans, and understand the basic review timeline.
Q: What's your experience with regulatory documentation?
Expected Answer: Should describe basic understanding of regulatory documents, attention to detail, and any experience with document management systems.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA regulations
- Document preparation and organization
- Understanding of submission requirements
- Basic knowledge of clinical trials
Mid (2-5 years)
- IND application preparation
- Cross-functional team coordination
- FDA communication experience
- Quality control procedures
Senior (5+ years)
- Strategic regulatory planning
- Management of multiple IND submissions
- FDA meeting experience
- Team leadership and mentoring
Red Flags to Watch For
- No knowledge of current FDA regulations
- Lack of attention to detail in documentation
- Poor understanding of clinical trial processes
- No experience with regulatory submissions
- Unfamiliarity with document management systems
