Senior Regulatory Affairs Specialist
LocumTenens(3 months ago)
About this role
A Regulatory Affairs Specialist at USAntibiotics supports regulatory compliance and prepares electronic regulatory submissions for pharmaceutical products, including INDs, NDAs, and ANDAs. The role assists with product lifecycle management and provides cross-functional support for pharmacovigilance and safety reporting under departmental direction. The position maintains awareness of FDA and ICH requirements and coordinates with internal and external stakeholders.
Required Skills
- Regulatory Submissions
- eCTD
- Pharmacovigilance
- Labeling Review
- FDA Interactions
- Project Management
- Communication
- XML
- SAP
- Document Management
+2 more
Qualifications
- Bachelor's Degree in Scientific Field
- Regulatory Affairs Certification (preferred)
About LocumTenens
locumtenens.comLocumTenens.com specializes in the temporary placement of physicians, advanced practitioners, psychologists, and social workers at healthcare facilities across the U.S. through onsite and telehealth services.
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