Krystal Biotech, Inc. · 2 days ago
Regulatory Affairs Administrator / Assistant
Pittsburgh, PA
Full-time
Onsite
Entry Level
1+ years expKrystal Biotech, Inc. is a biotechnology company focused on the discovery, development, and commercialization of genetic medicines. They are seeking a highly motivated Regulatory Affairs Administrator / Assistant to support regulatory documentation and document control activities, ensuring compliance with regulatory standards and internal templates.
BiopharmaBiotechnologyHealth Care
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
Qualification
Required
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
Company
Krystal Biotech, Inc.
A commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines for high unmet medical needs.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$546MKey Investors
Frazier Healthcare PartnersSun Pharmaceutical Industries
2023-05-21Post Ipo Equity· $160M
2021-11-29Post Ipo Equity· $200M
2021-02-02Post Ipo Equity· $100M
Leadership Team
Suma Krishnan
Founder & President
Recent News
GlobeNewswire
2026-01-11
Company data provided by crunchbase