Regulatory Sciences Expert Leader

5 days ago


Stockholm, Stockholm, Sweden ProPharma Group Full time

ProPharma Group is a world-leading Research Consulting Organization (RCO) that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies.

Job Description

We are seeking an experienced Senior Manager, Regulatory Sciences to lead our client projects and teams through all project phases. As a key member of our team, you will be responsible for:

  • Leading discreet client projects and leading project teams to ensure efficient project execution.
  • Authoring global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, marketing authorisation applications, contributing to gap analyses and regulatory strategies.
  • Project Management of assigned projects in accordance with internal procedures – including approval of time entry and invoicing, budget monitoring, client liaison and service growth.
  • Providing expert guidance and technical expertise, managing complex tasks and contributing to overall project strategy.
  • Leading interactions with clients and regulatory agencies on defined projects.


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