Senior Director, Regulatory Operations

The Senior Director of Regulatory Operations is responsible for directing all activities of the Regulatory Operations group, including defining the strategic goals, setting priorities, and overseeing all health authority submissions, and managing internal and external publishing staff. This position requires expert knowledge of global health authority submission requirements, electronic document management systems and publishing technologies. Drives improvement and efficiencies in Regulatory Information Management systems landscape, leads systems projects and oversees RA compliance activities, as assigned.

Responsibilities

  • Defines the strategic goals and direction for the Regulatory Operations group. Directs the activities of the Regulatory Operations group, including setting priorities for Regulatory submissions, and aligning with Global Regulatory Leadership team on the timing of key submissions.
  • Oversees and manages all Regulatory Operations submissions, systems related projects and submission compliance. Key contact for all enterprise system related timelines and projects for Regulatory Information Management.
  • Leads Regulatory technology projects and maintains project times and reports to Senior Management about these. This includes leading in the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects.
  • Responsible to proactively follow advancements in the technology field and propose strategies to increase efficiencies and compliance in managing submissions and document management within SMP Oncology and in collaboration with vendors.
  • Manages the activities of internal and external publishing staff contracted to publish and dispatch health authority submissions.
  • Leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, trains colleagues and project teams.
  • Contributes to the main budget and forecasts for Regulatory Affairs. 
  • Works on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to Health Authorities. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
  • Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.
  • As assigned, oversees RA compliance and quality activities (training, onboarding, quality metrics for submissions, CAPA management, support of inspections) as key partner for Quality Assurance.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree required; advanced degree preferred.
  • 15+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry.
  • Strong leadership skills in leading teams, complex projects, or strategic initiatives within Regulatory and cross-functional teams. Experience in coaching and managing others.
  • Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. 
  • Strong communication, strategic thinking, and problem-solving skills coupled with strong presentation skills.
  • Robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions. Advises and/or trains project teams on new requirements, along with proposals for implementation.
  • Overall understanding of drug development and business processes.
  • Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.

Job Location: Remote

Equal Opportunity Employer

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