Regulatory Affairs Specialist
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