Principal reg affairs specialist – São Paulo/SP

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

Responsabilidades

• Preparation, assembly and review 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.
• Support to the bidding team by sharing local regulatory intelligence.
• Development and implementation of project-specific processes.
• Attendance of meetings with local associations and participation in initiatives to foster clinical trials in Brazil.

Requisitos

• 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.
• 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 and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables.
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines.
• Excellent analytical, investigative and problem-solving skills.