Manager, Regulatory Operations

Manager, Regulatory Operations Job Description Template

Our company is looking for a Manager, Regulatory Operations to join our team.

Responsibilities:

  • Oversee compliant archiving of all regulatory documents with permissions in place for access;
  • Manage the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards;
  • Manage the process from inception to approval;
  • Provide functional and technical guidance with respect to submission of clinical trial applications and marketing applications;
  • Manage and maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence and commitments;
  • Oversee global publishing and submission process for domestic and international regulatory bodies;
  • Manage projects with vendors and contractors to meet schedules and ensure quality;
  • Utilize systems and tools for electronic document capture, generation, manipulation, scanning and QC.

Requirements:

  • Creative thinker, motivational leader, strong manager;
  • Advanced degree in a related field;
  • At least 5 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology or Pharmaceutical industries;
  • Strong team member and collaborative team player;
  • Passionate about growing a strong and productive global regulatory operations organization;
  • Proven leadership and program management experience;
  • Strong communication skills, both oral and written;
  • Strong computer skills, project management skills, and a high attention to detail; and.