Regulatory Affairs Specialist
$28 - $30 per hourAA2IT
Regulatory Affairs Specialist
Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $28-30/HR OPEN to remote candidates
Assist Regulatory Personnel with the Completion of Work Packages for Development Projects:
- Draft Meeting Requests and Briefing Packages for FDA meetings, Investigational New Drug Applications, Supplemental Biologic License Applications, Supplements to Marketing Applications (Labeling, Efficacy, and CMC), Pediatric Study Plans, Orphan Drug Applications, Clinical Trial Supporting Documents (Protocol Amendments, Investigator Updates, Investigator's Brochure, harmonization request, IND Safety Reports).
- Assist Regulatory Personnel with Labeling and Artwork Maintenance: Review and perform quality checks of labeling and artwork updates for all products.
Kindly share updated resume with answers:
Q1: How many years of exp in A: Regulatory Affairs B: FDA submissions C: IND / BLA D: CMC documentation E: Labeling review F: Artwork review G: Clinical regulatory support H Regulatory operations
Q2: Are you open to work remote and open for 4-6 months work
Vacancy posted 4 days ago
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