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.