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Associate Director, Regulatory Affairs Project Management

Cambridge, Massachusetts

Post Date: 09/14/2017 Job ID: 1567 Job Category: Clinical: Regulatory

The Associate Director, Regulatory Affairs Project Management has overall responsibility for managing submission projects involving multiple cross-functional teams. Working with Regulatory Affairs and Regulatory Operations, the Submission Manager establishes and maintains submission plans and associated timelines and runs tactical submission team meetings. The Individual is recognized as a discipline expert and resource.

Job  Responsibilities:
  • Manage operational oversight to ensure timely, high quality regulatory submissions.
  • Work with program teams to formulate submission plans, including timelines and deliverables.
  • Manage multiple projects and competing priorities.
  • Plan and conduct submission team meetings.
  • Act as interface with project teams to ensure that timelines and document requirements are mutually understood and in line with health authority standards.
  • Communicate effectively verbally and in writing, across various levels within the organization.
  • Contribute to the development of submission processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Identify opportunities for efficiencies and process improvements.
  • Demonstrate team leadership skills and ability to influence. Build and maintain positive relationships internally and externally.
  • Train and mentor junior staff

Qualifications/  Requirements:
  • Bachelor’ s degree
  • Minimum of 5 years of regulatory experience in pharmaceutical industry
  • Experience preparing regulatory submissions in eCTD format (including NDAs/BLAs, sNDAs, INDs, CTAs, DSURs, annual reports, meeting packages) and managing projects
  • Ability to coordinate regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication.
  • Must have a solid understanding of FDA regulations and ICH guidance’ s.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills both oral and written
  • Proven leadership skills and presence

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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