Regulatory Affairs Product Lead

On Application
27 Nov 2018
27 Dec 2018
Contract Type

Regulatory Affairs Product Lead – Sweden

Job Responsibilities

  • Manage direct interactions with local Nordic and Baltic regulatory authorities
  • Act as country RA product lead with primary national regulatory responsibilities for Sweden and Iceland for assigned product franchise(s)
  • Facilitate preparation for scientific advice meetings with national agencies
  • Provide regulatory input and support to health technology appraisal/horizon scanning for product portfolio
  • With PV, proactively assess any risk minimisation activities and review educational materials
  • Be responsible for providing the consolidated feedback to the EU regulatory strategists / global labelling team
  • Overseeing updating all relevant national external databases
  • Ensure regulatory compliance in the country in accordance with local regulations and SOPs, on behalf of the MAH

Key Skills

  • Ability to challenge self and others to overcome barriers and deliver high-quality solutions to the business
  • Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking
  • Be effectively able to embrace change and to be able to flourish in a global structure, aligning people and processes to deliver excellence
  • Can create an open, collaborative environment of continuous improvement within LOC stakeholders and global functions
  • Have strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies


  • BSc / MSc in a scientific discipline
  • Experience in multinational companies in regulatory affairs
  • Experience with Nordics Regulatory Authorities
  • Swedish language skills would be advantageous

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading specialist life science recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.


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