Regulatory Affairs Specialist

Upsilon Global has partnered with a CRO to support an ongoingCardiovascular Studyin Brazil. As part of this collaboration, we are seeking aRegulatory Affairs Specialistto join the team and provide expertise in regulatory activities, ensuring the study progresses in line with local regulations.Location : BrazilStudy Focus : Cardiovascular Study (Heart Disease Phase II)Study Duration : 12 monthsFTE : 0.5Key Responsibilities : Oversee regulatory compliance for theCardiovascular Studyin Brazil.Prepare and submit regulatory documents, including regulatory filings to ANVISA (Brazilian Health Regulatory Agency).Manage interactions with regulatory authorities throughout the study lifecycle.Coordinate with internal and external teams to ensure all regulatory requirements are met.Assist in preparing documents for clinical trial applications (CTAs) and amendments.Provide regulatory guidance and support to ensure the study meets both local and international standards.Monitor the progress of regulatory submissions and follow up on approval statuses.Required Qualifications : Bachelor’s Degreein Life Sciences or a related field.At least3-5 years’ experienceinRegulatory Affairswithin clinical trials.Knowledge and experience withANVISAregulations and submission processes.Experience working onCardiovascular studiesor withinCardiovascular therapeuticsis highly preferred.Excellent understanding of regulatory compliance, document preparation, and submissions.Strong communication and organizational skills.Proficiency in bothEnglish and Portuguese .Please contactJuliana Madibaor call+44 203 875 9966for more details or to express your interest in this opportunity.