Associate Director Reg Affairs

This Biopharmaceutical company focuses on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. A global leader in complement inhibition, and has developed and markets products as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.

The Position

  • Lead a sub-team of CMC Specialists and manage all CMC activities for assigned products
  • Facilitate, across multiple sites/departments, the authoring, reviewing and approval of CMC filings per schedule
  • Prepare and present CMC project plans, and status reports, to senior management
  • Serve as the primary CMC liaison with Regulatory Affairs to define global filing strategies and schedules, CMC section requirements, and supporting documentation
  • Work closely with representatives of Regulatory Affairs, Manufacturing, Technical Services, Process and Product Development and Quality in the execution of responsibilities
  • Develop and maintain robust processes and SOPs for drafting, reviewing and approving CMC sections for new, clinical, and commercial drug filings
  • Write, review and edit CMC sections as required
  • Assist in the compilation of APRs as required
  • Work with CMC specialists to develop their performance objectives and monitor their performance against the objectives.

The Person

  • Quality or regulatory professional with 10 or more years of experience with biopharmaceutical or pharmaceutical industry
  • Proven ability to manage complex projects, timelines, and critical path submissions
  • Ability to lead cross-functional teams and lead / mentor CMC specialists

To learn more apply on line or call Shane Browne on +353 1 6321865.

Salary: On Application Location: Dublin City Centre