Recruiter's Glossary

Examples: Clinical Trials • Serialization • NDA

BLA

Term from Pharmaceutical Services industry explained for recruiters

A BLA (Biologics License Application) is an official request that companies submit to the FDA to get permission to sell biological products in the United States. Think of it like a very detailed product application that includes all the testing, manufacturing, and safety information about medicines made from living organisms. It's different from regular drug applications because biological products (like vaccines or gene therapies) are more complex than traditional medicines. This process is crucial for pharmaceutical companies launching new biological treatments.

Examples in Resumes

Managed submission process for multiple BLA applications to FDA

Led quality control team supporting BLA preparation and review

Coordinated with research teams to compile Biologics License Application documentation

Successfully shepherded BLA through approval process

Typical job title: "BLA Specialists"

Also try searching for:

Regulatory Affairs Specialist BLA Manager Regulatory Submission Specialist Biologics Regulatory Manager Regulatory Affairs Manager BLA Coordinator Regulatory Operations Specialist

Where to Find BLA Specialists

Professional Organizations

• Regulatory Affairs Professional Society (RAPS)
• Drug Information Association (DIA)
• BioPhorum

Job Boards

Professional Networks

Example Interview Questions

Senior Level Questions

Q: Can you describe your experience managing a complete BLA submission from start to finish?

Expected Answer: Should demonstrate experience leading entire submission process, including timeline management, coordinating with multiple departments, handling FDA communications, and resolving complex regulatory issues.

Q: How do you handle disagreements between FDA reviewers and your development team?

Expected Answer: Should show diplomatic approach to balancing FDA requirements with company objectives, experience in negotiation, and ability to find solutions that satisfy both parties.

Mid Level Questions

Q: What sections of a BLA are you most familiar with?

Expected Answer: Should be able to discuss main BLA components like product quality, clinical data, and manufacturing information, with examples of their involvement in preparing these sections.

Q: How do you ensure quality control in BLA documentation?

Expected Answer: Should explain document review processes, quality checking procedures, and systems used to maintain accuracy and consistency in regulatory submissions.