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Job Details

Regulatory Affairs Product Lead

Company: Hobson Prior
Location: Sweden
Reference: RAProdLead
Closing Date: 27 Dec 18
Type: Contract
Salary (£): On Application
Benefits: Excellent package

Job Summary:

Hobson Prior is currently recruiting for a Regulatory Affairs Product Lead job at a leading global biopharmaceutical company. They are seeking a candidate who can bring their RA experience to the team to work as the Nordic Product Lead at their offices in Sweden. This is an exciting management opportunity for a leader to work closely with the Nordic-Baltic Regulatory Lead, oversee the regulatory strategy for a well-established pharmaceutical company and have the opportunity to travel.

Requirements:

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

Requirements

  • 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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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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