Regulatory Affairs Administrator / Assistant

Krystal Biotech • Pittsburgh, PA

1d • Onsite

About The Position

Krystal Biotech, Inc. is seeking a highly motivated Regulatory Affairs Administrator / Assistant to support regulatory documentation and document control activities. This new role within the RA department will focus primarily on document formatting, quality control, and lifecycle management to ensure regulatory documents meet high-level standards.

This role is well-suited for candidates eager to gain dynamic experience in a regulated biotechnology environment. The position will work onsite with the team at our Pittsburgh facility.

Requirements

• 1+ year of experience working with regulated documentation in a Regulatory Affairs, Clinical Operations, Quality, or similar regulated environment
• Associates or Bachelors Degree Required
• Strong attention to detail with demonstrated experience managing regulated documentation
• Proficiency with Microsoft Word, document formatting tools, and document management systems; TMF experience is a plus
• Excellent written and verbal communication skills
• A highly motivated self-starter who is organized, dependable, and able to manage shifting priorities
• Ability to work collaboratively within a dynamic, cross-functional team

Responsibilities

• Support document control activities for Regulatory Affairs, including formatting, version control, archiving, and document lifecycle management
• Format regulatory documents to ensure compliance with internal templates, style guides, and regulatory standards (e.g., bookmarks, hyperlinks, table of contents, pagination)
• Assist with planning, editing, formatting, tracking, compiling, and quality-checking regulatory documents and submission components
• Maintains calendars and schedules to ensure submissions are handled in appropriate timeframes
• Work cross-functionally with Clinical, Product Development, Quality, Manufacturing, and other functions to ensure documentation accuracy and completeness
• Provide administrative and documentation support related to regulatory submissions and internal regulatory records
• Support Clinical Operations, as needed, with filing, organizing, and quality review of documents within the Trial Master File (TMF)
• Perform other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 251-500 employees