Project Manager, Regulatory Affairs

San Rafael, CA 94901 | Contract

Post Date: 09/14/2017 Job ID: 3314 Industry: Regulatory Affairs & Compliance

Our client  focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


  • Our Regulatory Affairs organization, made up of a team of over 70 dedicated professionals, continues to grow.
  • If you are an experienced Project Manager with knowledge of drug development, interested in working in an environment where you' ll have the resources and infrastructure to tangibly impact patient' s lives, we want to talk with you.
  • Manage Regulatory Sub-team operations, including facilitation of Subteam and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
  • Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
  • Document project milestones/deliverables and report progress against team, department, and corporate goals.
  • Facilitate short and long-term planning activities.
  • Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.
  • Coordination across multiple departments: Clinical Science, Development PM, PharmSci, Manufacturing, Biostats.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Uses professional concepts and company' s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.



  • At least 5 years' experience in a project management or scheduling environment; a minimum of two years' experience managing teams and team operations.
  • Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology.
  • MS Project Server experience helpful.
  • Pharma/biotech or related industry experience required.
  • Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
  • Knowledge of Regulatory Affairs submissions and nomenclature desirable.
  • Exposure to electronic document management system(s) (EDMS) helpful.



  • Bachelor's degree required.
  • Project Management Professional and/or Regulatory Affairs Certification a plus.
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