Manager, Regulatory Affairs job in Bethesda at Technical Resources International
Technical Resources International
Bethesda, Maryland
This job has expired.
- 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.
Recommended Skills
- Biochemistry
- Immunology
- Management
- Multitasking
- Communication
- Toxicology
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