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Regulatory Project Manager

Your Role:

An exciting new opportunity has arisen to join EMD Serono as a Sr. Regulatory Project Manager. In close collaboration with the Global Regulatory Lead you are accountable for the operational aspects of regulatory deliverables within Development Projects. As a member of the regulatory sub team you plan, manage, track and ensure on-time production of regulatory deliverables for all submissions during development including initial MAA for US and EMA. As the leader of the Submission Taskforce you lead a cross functional team ensuring delivering of all dossier components, review and approval for submissions and coordinating the response to questions. As subject matter expert in the Global Project Team you provide timelines, direct cost demand and dashboards for Global Regulatory Affairs.You coach junior regulatory project managers and actively participate to the development of competences within the Regulatory Affairs project manager community.As a Sr. Regulatory Project Manager, you are reporting to the Head of Regulatory Project and Submission Management who is based in GRA Operations.

 

Who you are:

 

  • 8+ years’ experience in pharmaceutical industry, with 6 years of regulatory or regulatory operations experience, or equivalent.
  • Thorough understanding of the Regulatory Operations area, including processes and technology solutions.
  • Demonstrated experience in dossier creation and submission in US and EU.
  • Strong project management skills/experience, international project experience.
  • High attention to detail and strong organizational skills, work independently, self-motivated and proactive.
  • Ability to establish close communications and working relationship with cross functional teams to meet business objectives
  • Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements
  • Strong negotiating, influencing and interpersonal skills especially regarding indirect people leadership in a matrix organization.

 

 

Job Requisition ID:  188951
Location:  Billerica
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Nearest Major Market: Boston

Job Segment: Medical, Project Manager, Pharmaceutical, Manager, Healthcare, Technology, Science, Management

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