Regulatory Affairs Associate
Company: VirtualVocations
Location: Detroit
Posted on: January 28, 2025
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Job Description:
A company is looking for a Regulatory Affairs Associate
responsible for managing and compiling CMC sections of marketed
product variations.
Key Responsibilities
Manage and compile CMC sections for marketed product variations,
ensuring timely submission document preparation
Coordinate activities with functional departments to support
regulatory filings and develop project timelines
Facilitate project team meetings and ensure thoroughness, accuracy,
and timeliness of CMC dossiers
Required Qualifications
Bachelor's Degree in a Science-related field
4 years of experience in the pharmaceutical industry, with 1-2
years in cross-functional project management
Preferred 5 years of pharmaceutical experience, including 1-2 years
in regulatory affairs or related fields
Experience with regulatory submission documentation and electronic
document management systems
Familiarity with US and international regulatory requirements for
dossiers
Keywords: VirtualVocations, Detroit , Regulatory Affairs Associate, Other , Detroit, Michigan
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