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Project Manager, Regulatory

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  • 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.

Bachelor’s degree required.

Project Management Professional and/or Regulatory Affairs Certification a plus.

Bachelor’s degree required.

Project Management Professional and/or Regulatory Affairs Certification a plus.

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