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Regulatory Affairs Project Manager

Cambridge, Massachusetts

Post Date: 11/30/2017 Job ID: 1767 Job Category: Clinical: Regulatory

My client is seeking a Regulatory Affairs Project Manager. The ideal candidate will provide project leadership and overall coordination for regulatory filings.  This role will collaborate cross-functionally to create and manage regulatory operational project plans.   This position reports to the Sr. Vice President of Regulatory Affairs and Quality.

Job Responsibilities:
  • Develop detailed project plans for regulatory submissions
  • Work with team(s) to draft plans, define content, assign project responsibilities, determine project timelines and ensure senior management review and approval
  • Manage regulatory affairs project meetings, obtain updates from various team members in order to track progress being made against timelines, notify management of critical issues and update timelines/database as appropriate
  • Participate in cross-functional development team meetings
  • Manage the completion of action items and drive the resolution of issues


Qualifications/Requirements: 
  • Bachelor’ s degree required, Master’ s degree in scientific discipline preferred
  • 8+ years of regulatory affairs experience in the pharmaceutical industry
  • Extensive hands-on experience and successful track record with regulatory submissions (IND’ s, CTA’ s NDAs, CTDs/eCTDs) required
  • Knowledge of regulatory processes, guidelines, regulations, submission/registration types and requirements and GxPs (GCPs, GLPs, GMPs)
  • Strong collaboration and verbal/written communication skills
  • Proven ability to manage projects and timelines and organize/track complex information
  • Highest ethical standards and focus on quality and details

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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