Freelance Full Time Part Time Temporary

Freelance Senior Global Regulatory Affairs

Urgent
Posted 2 weeks ago
Application ends: October 29, 2021
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Job Description

AL Solutions have partnered with a small CRO specializing in Oncology and Rare Disease studies, they have a global presence and are looking to Support their existing Regulatory affairs department with Freelance Senior Regulatory Affairs Associate.

Offering remote working from UK, France, Spain, Hungary, Italy & Germany.  Looking for a freelancer to assist them until at least February.

Duties

  • Leading Regulatory activities for complex global & early phase clinical trials
  • Prepare, review and submit clinical trial applications to Regulatory Authorities, Ethics Committees across the global
  • Aid with producing investigator brochures, protocols, IMPDs and other reg documents
  • In charge of patient information documents
  • Actively working with project managers helping monthly financial reports on project
  • Assisting with development of fellow colleagues through mentoring and training
  • Performing duties developing & writing SOP’s and helping with business development activities

Required

  • Bachelors Degree within Science or Medical field
  • In depth knowledge of submitting clinical trials applications across different countries
  • Experience with EU directive and National requirements for clinical trials
  • Previously performed project reporting, Liaising with multiple stakeholders including clients and international operational teams
  • Analytical, planning, investigative minded and strong problem solving skills

Apply

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.