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Vice President, Regulatory Affairs
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- Job Description: The Vice President, Regulatory Affairs will join the Civica, Inc. ("Civica") organization and its team by bringing their knowledge and experience in service to patients and pursuit of excellence to secure and stabilize the supply of sterile generic injectable medications and provide affordable specialty medications and insulin biosimilar analogs to patients within the United States.
- The Vice President, Regulatory Affairs: Leads Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development (including biologic/device combination products), review, submission, and FDA approval of Civica's medication portfolio.
- Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
- Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
- Oversee regulatory affairs operations including the VEEVA regulatory information management (RIM) platform, and the artwork management system for both Civica owned and private label distribution products.
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