Overview

Seeking an experienced Regulatory Affairs professional with a solid understanding of the regulatory submissions and drug development processes. IND/NDA submissions experience is critical for this FT, Princeton-based position. Candidates with additional experience in any of the following areas – clinical trial management, clinical development, clinical science – are highly desired. Solid fluency with MS Project and strong project management, presentation, and communication skills are also required. 

 

Responsibilities

  • Act as a central contact/lead for managing regulatory (especially NDA) submission activities, teams and information
  • Provide professional leadership and direction for regulatory submission programs
  • Ensure submissions follow ICH guidelines and worldwide submission regulations/guidelines
  • Work with publishing teams and company stakeholders to achieve:
    • Publishing/submission readiness
    • Electronic/paper publishing requirements
    • Regulatory compliance
  • Maintain project actions, deliverables, risks, decisions, issues, and schedules using Microsoft Project
  • Ensure that concurrence between the team and management is achieved for program objectives and meet these objectives to achieve goals
  • Facilitate review of submission projects with senior management, make recommendations for actions, project requirements, resource needs, and regulatory alignment
  • Ensure appropriate follow-up by management to achieve submission goals and objectives

 

Qualifications

  • Experience and sound working knowledge of the IND, NDA/BLA and CTD submission process/regulations
  • Pharmaceutical/biotech industry experience
  • Understanding of eCTD submission requirements, submission compilation and application requirements, current applicable regulations
  • Solid experience with submission publishing software
  • Understanding/familiarity with the execution of clinical trials
  • Experience and knowledge to guide teams and prepare for regulatory interactions/submissions
  • Solid fluency with Microsoft Project
  • At minimum a Bachelor’s degree; Master’s degree desirable
  • RAC desirable

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