Manager, Regulatory Affairs at Technical Resources International

Posted in Other 30+ days ago.

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Location: Bethesda, Maryland

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.

Job Requirements
  • Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
  • Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
  • Superior organizational skills and customer service abilities.
  • Ability to analyze medical research data and review experimental protocols.
  • Strong working knowledge of Microsoft office; experience with SharePoint a plus.
  • Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
  • Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
  • Ph.D. or M.S. or equivalent with related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, regulatory affairs, or other applicable field
  • 3+ years