PSI CRO AG logo
PSI CRO AG

The global CRO where clinical trials run on time.

Regulatory Officer

ComplianceComplianceFull TimeRemoteSeniorTeam 1,001-5,000Since 1996H1B No SponsorCompany SiteLinkedIn

Location

Canada

Posted

19 days ago

Salary

$70K - $90K / year

Seniority

Senior

Bachelor DegreeEnglishFrench

Job Description

Regulatory Officer

PSI CRO AG

• Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, with a specific focus on Canadian and US regulatory submissions, including Import and Export license applications • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters • Review translations of essential documents subject to clinical trial submission • Track the regulatory project documentation flow • Review documents to greenlight IP release to sites • Manage safety reporting to authorities • Deliver regulatory training to project teams • Assist with feasibility research and business development requests

Job Requirements

  • College/University degree or an equivalent combination of education, training and experience
  • Prior experience with clinical trial submissions in North America
  • Full working proficiency in English and French, native French speaker competency required, US Spanish speaker competency beneficial
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

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