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For your reference, we have included the original job posting below.
Regulatory Affairs Mgr (CMC Product Team)
Job Number:
43496347
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Science & Biotech Healthcare & Medical
Regulatory Affairs Mgr (CMC Product Team)
The purpose of this group is to facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Job Summary: The RA CMC Product team is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of regulatory strategy. The RA CMC Product Lead is member of the product team , the Global Operations Team, Global Regulatory Team and is responsible for communicating to regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and coordination with the site and regional CMC representatives on the CMC GRT to develop and execute global regulatory activities.
Key Activities: - Contributes to one or more product teams - May act as product lead for one or more products - Provides strategic regulatory input and regulatory risk assessments for product teams - Executes regulatory strategy with respect to preparation of submissions - Complies with critical RA CMC processes - Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance - Reports needs for process changes to CMC systems and contributes to process improvements - Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams - Reports issues to RA CMC product team management
Knowledge and Skills - Microsoft Suite: Word, Excel, PowerPoint, Outlook - CMC- specific regulatory knowledge & experience
Basic Qualifications - Doctorate degree OR - Master's degree and 3 years of directly related experience OR - Bachelor's degree and 5 years of directly related experience OR - Associate's degree and 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience
Preferred Qualifications - Degree in Life Science discipline - Experience in manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry - Regulatory CMC experience
