North American Regulatory Affairs Specialist for Clinical Trials

3 semanas atrás


São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
About the Role

We are seeking a highly skilled North American Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will be responsible for providing innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization.

Key Responsibilities
  • Support the preparation of documentation and submissions under guidance.
  • Coordinate and manage client deliverables ensuring regulatory compliance.
  • Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.
  • Exhibit good negotiation skills and the capability to work independently with direction, exercising independent judgment.
Requirements
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years.
  • Good English language (written and oral) communication skills as well as local language where applicable.
  • Good attention to detail and quality as well as editorial/proofreading skills.
  • Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects.
Working Conditions

The ideal candidate will have strong analytical, investigative, and problem-solving skills, with the ability to interpret data and understand medical terminology, statistical concepts, and guidelines.

Compensation and Benefits

We offer an estimated salary range of $80,000 - $110,000 per year, depending on location and experience. In addition to a competitive salary, we provide a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.



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