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Management Job ? Then, This is the place where you can find All sources of Job opportunities with detailed information.
| Job Category : |
Management |
| Company Name: |
Technical Resources International, Inc. |
| Position Name: |
Manager, Regulatory Affairs |
| Location : |
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.
Recommended Skills
Attention To Detail Biochemistry Clinical Trials Communication Coordinating Customer Service
Job Snapshot
Employee Type
Full-Time
Location
Bethesda, MD
Job Type
Biotech
Experience
Not Specified
Date Posted
02/04/2022
Job ID
192/94/823 |
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