Country Regulatory Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

Job Summary:

We are seeking a highly skilled Country Regulatory Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in the management and preparation of local regulatory submissions, ensuring compliance with global submission strategies and regulatory guidelines.

Key Responsibilities:

  • Prepare, review, and coordinate local regulatory submissions, including MoH, EC, and special national local applications, in alignment with global submission strategies.
  • Provide local regulatory strategy advice to internal clients, ensuring compliance with regional and national regulatory guidelines.
  • Coordinate project-specific local SSU services and ensure alignment with submission activities and timelines.
  • May have contact with investigators for submission-related activities and serve as a key contact for ethical or regulatory submission-related activities.
  • Coordinate with internal functional departments to ensure site start-up activities are aligned with submission activities and timelines.
  • Achieve PPD's target cycle times for site activation.
  • May work with start-up CRAs to prepare regulatory compliance review packages and develop country-specific patient information sheets and informed consent forms.
  • Assist with grant budget and payment schedule negotiations with sites and support the coordination of feasibility activities.
  • Enter and maintain trial status information onto PPD tracking databases and ensure local country study files and filing processes are prepared and maintained.

Requirements:

  • Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
  • Excellent oral and written communication skills, interpersonal skills, and attention to detail.
  • Good negotiation skills, computer skills, and ability to learn software.
  • Basic medical/therapeutic area and medical terminology knowledge.
  • Ability to work in a team environment or independently, under direction, as required.

What We Offer:

As a Country Regulatory Specialist at Thermo Fisher Scientific, you will have the opportunity to work with a talented team of professionals, contribute to the success of our regulatory affairs team, and develop your skills and expertise in regulatory compliance and submission strategies.

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