Manager, CMC Regulatory Affairs - U.S. Market
Bracco(4 months ago)
About this role
The Manager, CMC Regulatory Affairs at Bracco leads the development of chemistry, manufacturing and controls (CMC) regulatory strategies and prepares Module 3 (or equivalent) filing documentation to support registration and lifecycle management of contrast agent products in the U.S. market. The role represents U.S. CMC regulatory expertise within cross-functional teams and monitors FDA requirements to ensure compliant submissions and post-approval maintenance.
Required Skills
- CMC Regulatory
- FDA Compliance
- Module 3
- Regulatory Strategy
- Risk Mitigation
- Veeva RIM
- Technical Writing
- Project Management
- Sterile Manufacturing
- Organic Synthesis
+1 more
Qualifications
- Master's Degree in Chemistry, Pharmacy, or Chemical Engineering
- PhD Preferred
About Bracco
bracco.comSince the kick-off in 1927, Bracco has grown to become a leading authority in improving people’s lives by shaping the future of prevention and precision imaging.
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