Regulatory Operations Specialist
Regulatory Operations Specialist
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Not Disclosed
Salary Not Disclosed
Job Description
Position: Regulatory Operations Specialist
Working hours: USA time zone
Salary: 3.000 to 4.000 USD/m
Type of contract: independent contractor.
Requirements
310 years of experience in regulatory filings to both FDA and EMA (IND Scientific Advice NDA MAA DSUR reports etc.)
Familiarity with CMC nonclinical and clinical modules a plus.
Ability to draft cover letters and complete FDA forms.
Experience with IND (Investigational New Drug) and NDA (New Drug Application) submissions.
ECTD publishing software and sage Microsoft Word templates are advantageous.
Handson experience with eCTD publishing software specifically Lorenz DocuBridge from Lorenz.
Excellent language and writing skills.
PDF creation/editing skills.
Employment Type
Full Time
