Principal regulatory affairs specialist – São Paulo/SP [remoto]

SP l São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista

Responsabilidades

• Lead discussions and coordinate regulatory strategies for submissions in Brazil on assigned Phase 1 to 4 clinical trials, studies and projects.
• Provide strategic regulatory intelligence and guidance, interacting with internal team members and, if needed, directly with clients.
• Provide regulatory advice and carry out projects in the provision of regulatory affairs services while acting as liaison with internal and external clients.
• Act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement.
• Arrange, lead, and report on regulatory agency meetings as a local expert.
• Prepare, assemble and review local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs, biologics, advanced therapies and devices.
• Discuss regulatory strategy for each project.
• Interact with sponsors and internal teams.
• Interact with local regulatory authorities, including meetings and audiences.
• Review and assess clinical trial regulatory documents.
• Review and assess scientific literature.
• Support the bidding team by sharing local regulatory intelligence.
• Attend meetings with local associations and participate in initiatives to foster clinical trials in Brazil.

Requisitos

• QUALIFICAÇÕES MÍNIMAS.
  • Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job.
  • Knowledge of the local and global clinical trials landscape.
  • Excellent command of the English language, written and oral, as well as local language.
  • Excellent attention to detail and quality, as well as excellent editorial and 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 and PowerPoint; 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 and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables.
  • Great understanding of national country requirements and regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines.
  • Good analytical, investigative and problem-solving skills.
• QUALIFICAÇÕES PREFERENCIAIS.
  • Advanced degree.