Regulatory Affairs Specialist
3 weeks ago
* Preparation of regulatory documents, including electronic Common Technical Documents (eCTD) format and structure
* Planning, editing, formatting, tracking, compiling, and publishing regulatory submissions
* Maintaining calendars and schedules to ensure submissions are handled in appropriate timeframes
* Collaborating with cross-functional teams, including Clinical, Product Development, Quality, Manufacturing, and others to ensure accuracy of information provided in submissions
* Identifying process improvement opportunities within the 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
* 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. 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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