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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

Brazil

Posted

58 days ago

Salary

0

Seniority

Senior

Bachelor DegreePortugueseEnglish

Job Description

Regulatory Officer

PSI CRO AG

• Prepare clinical trial documents for Regulatory and Ethics submissions • Communicate with regulatory authorities and support communication with 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 to ANVISA in Brazil
  • Prior experience with regulatory activities for clinical trials
  • Full working proficiency in English and Portuguese, Spanish is a plus
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

Benefits

  • Excellent and flexible working conditions
  • Extensive training and friendly, collegial team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

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