Regulatory Affairs Specialist

3 weeks ago


Pittsburgh, Pennsylvania, United States Krystal Biotech, Inc. Full time
About Krystal Biotech, Inc.

Krystal Biotech, Inc. is a cutting-edge biotechnology company that is revolutionizing the field of genetic medicine. We are seeking a highly motivated Regulatory Affairs Associate to join our team and support all regulatory activities from product development and pre-clinical through product approvals.

Key Responsibilities:
  • Prepare and submit regulatory documents in eCTD format, ensuring accuracy and timeliness.
  • Collaborate with cross-functional teams, including Clinical, Product Development, Quality, and Manufacturing, to ensure regulatory compliance.
  • Identify process improvement opportunities and implement changes to enhance regulatory function.
  • Develop and maintain regulatory Standard Operating Procedures and systems.
  • Perform other duties as assigned.

Requirements:
  • 1-3 years of regulatory experience in a pharmaceutical or biotechnology environment.
  • Experience with regulatory submissions in eCTD format.
  • Bachelor's degree in a scientific or related field.
  • Excellent scientific writing, communication, and analytical skills.
  • A self-starter with a proactive approach and ability to work in a dynamic team environment.

Equal Employment Opportunity:
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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