Upvote
Downvote
Vice President Regulatory Affairs
Share Job
- Suggest Revision
- It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
- 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.
- Leads the regulatory team in the development and compilation/publishing of documentation for U.S. FDA investigational new drug (IND), European Medicines Agency clinical trial application (CTA)/investigational medicinal product dossier (IMPD), Abbreviated/New Drug Applications (A/NDA), and biologics license application (BLA) submissions, FDA meeting requests, and correspondence and responses to questions from regulatory authorities, including FDA.
- 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.
Active Job
Updated 9 days agoSimilar Job
Relevance
Active