Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About the Role

Are you looking to make a significant impact in the world of scientific research? As a Country Approval Specialist at Thermo Fisher Scientific in São Paulo, Brazil, you will play a pivotal role in driving our mission forward. This outstanding opportunity allows you to collaborate with a world-class team, applying your expertise to ensure flawless regulatory approval processes. Join us in our ambitious journey to innovate and excel in the research field.

Key Responsibilities

Prepare, review and coordinate local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. Develop and review country and site-specific Informed Consent form documents.Work collaboratively with cross-functional teams to determine and implement approval strategies.Prepare and submit regulatory documents to successfully acquire necessary approvals.Maintain clear and effective communication with stakeholders, providing updates and insights on approval status.Maintain contact with investigators for submission related activities and serve as a key contact at country level for either Ethical or Regulatory submissions related activities. Identify and implement process improvements to improve efficiency and effectiveness.Assess and mitigate risks associated with regulatory approvals.

Qualifications

Education: Bachelor’s degree or equivalent experience in a related field; advanced degree preferred.Experience: Proven experience in regulatory affairs or a similar role within the research industry.Skills: Outstanding attention to detail, strong organizational skills, and the ability to manage multiple projects simultaneously.Language: Proficient in Portuguese and English, both written and spoken.Attributes: Demonstrated ability to work independently and collaboratively in a fast-paced, dynamic environment.

Join us and be part of a team that is dedicated to making a difference in the world. Your contributions will help us compete at the highest levels and achieve our mission of making the world healthier, cleaner, and safer.