Upsilon Global has partnered with a CRO to support an ongoing Cardiovascular Study in Brazil. As part of this collaboration, we are seeking a Regulatory Affairs Specialist to join the team and provide expertise in regulatory activities, ensuring the study progresses in line with local regulations.
Location: Brazil
Study Focus: Cardiovascular Study (Heart Disease Phase II)
Study Duration: 12 months
FTE: 0.5
Key Responsibilities:
* Oversee regulatory compliance for the Cardiovascular Study in 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 Degree in Life Sciences or a related field.
* At least 3-5 years’ experience in Regulatory Affairs within clinical trials.
* Knowledge and experience with ANVISA regulations and submission processes.
* Experience working on Cardiovascular studies or within Cardiovascular therapeutics is highly preferred.
* Excellent understanding of regulatory compliance, document preparation, and submissions.
* Strong communication and organizational skills.
* Proficiency in both English and Portuguese.
Please contact Juliana Madiba or call +44 203 875 9966 for more details or to express your interest in this opportunity.