Upsilon Global

Regulatory Affairs Managers

1 day left

Lombardy region
£60,000 - £75,000
02 Oct 2020
01 Nov 2020
Full Time
Contract Type
Experience Level
  • Coordinate the activities of the Italian RA team, including resource management
  • Establish operational objectives and performance goals for the team
  • Develop and implement training programs, quality systems, controls and documents at the local level
  • Participate in system audits and facilitate regulatory inspections
  • Prepare and review clinical trial submission dossiers for Regulatory and Ethics Authorities
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
  • Oversee the procurement of study-specific documents and translations of essential documents subject to clinical trial submissions
  • Oversee and review documents to greenlight IP release to sites
  • Oversee and manage safety reporting to authorities
  • Consult on feasibility research and business development requests
  • Participate in internal or client bid-defense or kick-off meetings, as required

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