Senior Regulatory Specialist

1 semana atrás

São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro R$55.000 - R$75.000
Regulatory Submissions Coordinator Role

We are growing our operations in Brazil and seeking a skilled Regulatory Submissions Coordinator to provide crucial support for our projects. This role offers the opportunity to gain vital experience and develop skills as a productive member of our team.

Key Responsibilities
  • Provide daily departmental/project support activities, such as collecting essential documents for ethics submissions and preparing study documents for regulatory bodies.
  • Support Regulatory Submission Managers and Start Up teams in ensuring timely completion of tasks.
  • Conduct quality control of documents to maintain high standards.
  • Offer guidance and advice to internal and external team members to ensure compliance with applicable regulations and requirements.
  • Perform other tasks as needed to contribute to project success.
Required Skills and Qualifications
  • A Life Science Bachelor's degree is required, with an advanced degree preferred (master's/PhD), and at least 3-4 years of regulatory submissions experience.
  • Experience with ANVISA (RA) submissions is necessary.
  • Experience with biosafety commission (CTNBio) submissions is desirable.
  • Interest or experience in regulatory surveillance and strategy is beneficial.
  • Excellent organizational and prioritization skills are essential.
  • Knowledge of Microsoft Office is required.
  • Great attention to detail and excellent oral and written communication skills are necessary.
  • Fluency in spoken and written English is required.

This is an exciting opportunity for individuals who possess strong organizational skills, attention to detail, and excellent communication skills. If you are passionate about working in a dynamic environment and contributing to the growth of our organization, please apply.

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