ALKU

Global Regulatory Project Manager

ALKU United States
No longer accepting applications

Global Regulatory Project Manager (RPM)

12 months + remote


Environment:

Our client is a large biotherapeutic company located in the Northeast that is currently seeking Global Regulatory Project Manager support. This is a fast paced environment and this person will be expected to hit the ground running.


Responsibilities:

The Global Regulatory Project Manager (RPM) will be a high level regulatory professional with project management expertise, responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables for global submissions. The ideal candidate will have extensive experience developing and managing a submission content plan and must have the ability to oversee multiple submissions simultaneously. They should have strong global experience, specifically with the EU.


The types of projects this individual will be overseeing are in the Respiratory area (COVID, FLU, RSV) which requires this person to have extensive Global Regulatory Affairs experience.


  • Project Manager - Regulatory (RPM Experience)
  • Global Regulatory Affairs
  • Development/Management of Submission Content Plan
  • Ability to manager multiple submissions at same time
  • Strong technical experience
  • Regulatory filing submission management
  • Managing projects for Respiratory (Flu, RSV or COVID)
  • Director level+

  • Seniority level

    Director
  • Employment type

    Contract
  • Job function

    Consulting and Project Management
  • Industries

    Biotechnology Research and Pharmaceutical Manufacturing

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