Manager, CMC Regulatory Affairs - U.S. Market
Bracco
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.
Skills
Qualifications
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.
Recent company news
PR NewswireBracco Delivers 3 Million VUEWAY® Doses, Meeting Patient Demand for Lower-Dose MRI Contrast
Nov 19, 2025
Genetic Engineering and Biotechnology NewsBracco Expands into Cell Therapy Space with Lipid-Based Microbubble Technology
1 month ago
BioProcess InternationalBracco enters cell-therapy manufacturing space with microbubble platform
1 month ago
The Medicine MakerBracco Targets Cell Therapy Manufacturing with Bead-Free Microbubble Cell Processing
4 weeks ago
The Business JournalsDallas Italian favorite il Bracco expands to Scottsdale with $100K art collection
2 weeks ago
About Bracco
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Bracco.
Salary
$160k – $208k
per year
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