What are the responsibilities and job description for the Regulatory Affairs Consultant position at iCell Gene Therapeutics?
Responsibilities
- Preparing and formatting new drug applications to the FDA
- Validation of document packages for IND submission
- Electronic submission of new drug applications to the FDA
- Salary commensurate with experience.
Qualifications
- An advanced degree in life sciences, medicine, or related fields
- At least 2 years of experience in writing IND documents for FDA submission
- Excellent writing, editing, and communication skills
- Expertise in publishing and validation software such as Lorenz Docubridge
- Experience with WebTrader software for FDA submission
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