Manager, Regulatory Affairs

16 Nov, 2022


Manager, Regulatory Affairs

Technical Resources International, In
Bethesda, MD

Full 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

  • Biochemistry
  • Immunology
  • Management
  • Multitasking
  • Communication
  • Toxicology

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Job posted: 2022-11-15