Director, Regulatory Affairs and Quality Project Management

3 days ago


San Francisco, California, United States Pliantrx Full time
Job Summary

Pliant Therapeutics is a leading biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. We are seeking a highly skilled Director of Regulatory Affairs and Quality Project Management to join our team.

Key Responsibilities
  • Manage regulatory milestones from early-stage research through clinical development to registration.
  • Develop and implement quality metrics and track quality-related activities.
  • Partner with regulatory strategists and quality team members to drive global filings into seamless executions.
  • Communicate clearly and provide clear direction to stakeholders.
  • Develop important relationships with key stakeholders and analyze issues to support relevant and realistic plans.
  • Support program recommendations and drive key kick-off regulatory submission meetings.
Requirements
  • BS degree in life sciences or business-related field, advanced degree preferred.
  • Minimum of 12 years professional experience with 8 years in project management in a pharmaceutical or biotechnology environment.
  • Demonstrated understanding of Regulatory and/or drug development processes.
  • Experience with global filings (NDAs/MAAs) and a submission background is preferred.
  • Strong organizational, project, and time management skills.
  • Effective communication skills, both written and verbal, which enable successful collaboration with stakeholders.
What We Offer

Pliant Therapeutics offers a dynamic and innovative work environment with opportunities for professional growth and development.



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