Regulatory Affairs Associate

2 weeks ago


Pittsburgh, Pennsylvania, United States Krystal Biotech Full time

Job Title: Regulatory Affairs Associate


About the Role:


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.


Key Responsibilities:



  • Preparation of regulatory documents, including electronic Common Technical Document (eCTD) format and structure.
  • 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 of 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.

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



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