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|Job Category :
|Technical Resources International, Inc.
|Manager, Regulatory Affairs
|6500 Rock Spring Dr # 650, Bethesda, MD 20817
|Job Description :
|Oversee Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs) and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
Coordinate the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
Work closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Supervise and manage Regulatory Team staff members, as assigned.
Lead and participate in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
Coordinate the maintenance of work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, trackers, etc.
Perform literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
Provide project management support for projects as needed.
Coordinate across projects as needed to ensure harmonization and knowledge sharing.
Provide oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
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