Senior Manager Regulatory CMC
Company: VirtualVocations
Location: Orange
Posted on: October 23, 2024
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Job Description:
A company is looking for a Sr. Manager, Regulatory CMC.
Key Responsibilities
Collaborate with cross-functional teams to prepare and review CMC
sections of global regulatory submissions
Provide regulatory guidance on post-approval content and assess
proposed CMC changes for global impact
Communicate with regulatory Health Authorities and implement
current global regulations for CMC documentation
Required Qualifications
B.S. in a scientific discipline, preferably Chemistry; advanced
degree is a plus
6+ years of pharmaceutical industry experience in CMC Regulatory
Affairs, with a focus on small molecules
Experience in leading high-quality CMC regulatory submissions for
global marketing applications
Strong knowledge of global regulatory guidelines (FDA, EMA, ICH)
and cGMP
Previous experience with change controls and regulatory strategies
for global implementation
Keywords: VirtualVocations, Orange , Senior Manager Regulatory CMC, Executive , Orange, California
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