Regulatory Affairs Associate

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 Associate to support all regulatory activities from product development and pre-clinical through product approvals. They will play an active role in preparation of regulatory documents and ensuring submissions are quality in nature and on-time. The Associate will work onsite with the team, based in our Pittsburgh facility. Primary Responsibilities: Knowledgeable of electronic Common Technical Document (eCTD) format and structure Preparation of regulatory documents that meet appropriate standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems. Assist with planning, editing, formatting, tracking, compiling, and publishing regulatory submissions. Maintains calendars and schedules to ensure submissions are handled in appropriate timeframes Works cross-functionally with different departments, including Clinical, Product Development, Quality, Manufacturing, and others to ensure accuracy or information provided in submissions Identify process improvement opportunities within regulatory function, including creation and refinement of Regulatory Standard Operating Procedures and implementation of systems Other duties as assigned Experience and Skills Desired: 1-3 years of regulatory experience in a Pharmaceutical/Biotechnology environment Experience with regulatory submissions in eCTD format Bachelor's degree in a Scientific or related field Excellent scientific writing, other written and oral communication skills are required. A demonstrated self-starter who is highly motivated and able to address changing priorities. Ability to take a proactive approach on the job with the ability to work with a dynamic 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.

Created: 2024-11-02