Regulatory Affairs Associate
2 weeks ago
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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