Regulatory Affairs Specialist

4 weeks ago


Pittsburgh, Pennsylvania, United States Krystal Biotech Full time
Job Overview

Krystal Biotech is seeking a highly motivated Regulatory Affairs Associate to support all regulatory activities from product development and pre-clinical through product approvals.

Key Responsibilities
  • 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
Requirements
  • 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.
About Krystal Biotech

Krystal Biotech, Inc is an Equal Employment Opportunity and Affirmative Action Employer. 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.



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