Regulatory affairs specialist – São Paulo/SP [remoto]

Responsabilidades

• Support the preparation and compilation of local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs, biologics, advanced therapies and devices
• Interaction with sponsors, internal teams and regulatory agencies
• Review and assess clinical trial regulatory documents
• Enters and maintains trial status information relating to RA activities onto PPD tracking databases in an accurate and timely manner
• Ensures the local country study files and filing processes are maintained as per PPD WPDs or applicable client SOPs
• Participation in project team meetings
• Development and implementation of project-specific processes
• Attendance in meetings with local associations and participation in initiatives to foster clinical trials in Brazil

Requisitos

• What the role requires you to have:
  • Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job
  • Knowledge of the local and global clinical trials landscape
• Knowledge, Skills and Abilities:
  • Excellent command of the English language (written and oral) as well as local language where applicable
  • Excellent attention to detail and quality as well as excellent editorial/proofreading skills
  • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
  • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
  • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
  • Capable of working independently on the assigned tasks
  • Good understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines
  • Excellent analytical, investigative and problem-solving skills

Marcado como: Assuntos Regulatórios, Estudos Clínicos, Indústria Farmacêutica, Pesquisa Clínica