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Listed below are the top 10 out of 23 listings that are in the same industry and location as the job you were looking for. To see more than 10 listings, click here to search similar jobs in Thousand Oaks, CA
This is a high level position for a subject matter expert within the Drug Product Engineering Organization. They will be responsible for providing scientific ...
Baxter International, Inc - Westlake Village, CA US
Westlake Village, CA Req ID 53383BR Business Title Reg Affairs Ops Spec Business Medical Products SubBusiness Regulatory Affairs Country US State/Province ...
Baxter International, Inc - Westlake Village, CA US
Westlake Village, CA Req ID 53338BR Business Title Mgr, Reg Affairs Business BioScience SubBusiness BioScience Regulatory Affairs Country US State/Province ...
Baxter International, Inc - Westlake Village, CA US
Westlake Village, CA Req ID 53505BR Business Title Mgr, Clinical Data Mgmt Business BioScience SubBusiness Research and Development Country US State/Province ...
The Manager Statistical Programming will work in Amgen's Global Safety & Independent Biostatistics (GSIB) organization Programming team in the Cardiacrenal ...
GRAAS Biosimilar Policy is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars and advocating those standards ...
Biosimilars are an important new development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies ...
The Drug Delivery PMO is a function within Operations' Drug Delivery organization that provides portfolio and project management leadership to advance device ...
The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development ...
The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development ...
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
