Regulatory Affairs Administrator / Assistant

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Job Description Summary:

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.

Primary 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

Experience and Skills Desired:

• 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

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.