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As a Senior Regulatory Affairs Associate you will have the opportunity to work within Regulatory Authority Submissions related to Clinical Trials, supporting many projects in Brazil.
Previous experience submitting clinical trials to ANVISA is required.
Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with oversight from the Line Manager.
Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon tracking system; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified.
Escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.You will be a productive member of the team, and will be mentored and supported as you develop your skills.
Working directly with our team, you will gain valuable hands on experience to enable you to develop a career in clinical research.ResponsibilitiesFollows the project direction and expertise provided by the designated Regulatory Leader.
May serve as the primary point of contact for the study team regarding Regulatory Authority Submissions.Provide day-to-day departmental/project support activities.Prepares and submits RA Applications ensuring deadlines are met.Conduct quality control of documents.Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements.Oversees ongoing submissions, amendments, and periodic notifications required by RA, and other local regulatory authorities as needed within the country with oversight from the Line Manager.Qualifications:Bachelor's degree is required (preferably in a Life Sciences field) and at least 2 years of regulatory submissions experience.Good Organizational and prioritization skills.Client-focused approach to work.Teamwork and collaboration skills.Excellent interpersonal and intercultural communication skills, both written and verbal.Great attention to detail and results orientation.Critical thinking and problem-solving skills.Knowledge of Microsoft Office.Fluency in spoken and written English.Knowledge and Experience:Previous experience submitting clinical trials to ANVISA is required.
