IW
Regulatory Associate
Info Way Solutions LLC
🇺🇸 United States
Remote
6 months ago
6 months ago
Job Title: Regulatory Associate
Requisition : HCR0003161
Client: Merz
Job Description:
OPEN to remote candidates
•     Assist Regulatory Personnel with the Completion of Work Packages for Development Projects:
o     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:
o     Review and perform quality checks of labeling and artwork updates for all products."
Location: 6601 Six Forks Road, Raleigh, NC 27615
Regulatory Associate · Info Way Solutions LLC