# Senior Clinical Trial Regulatory Advisor

**Company**: Syneos Health
**Location**: ARG-Buenos Aires-Hybrid
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Buenos-Aires-Hybrid/Senior-Clinical-Trial-Regulatory-Advisor---Previous-experience-working-with-submissions-in-multiple-countries---Argentina_25113332?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_eefaa432-597

## Description

We are looking for a Senior Clinical Trial Regulatory Advisor to join our team in Argentina. As a Senior Clinical Trial Regulatory Advisor, you will be responsible and accountable for the customer-focused leadership and management of CTRA deliverables within a country, region or globally, within the assigned projects or programs during start-up, site activation and throughout the study life cycle.

Responsibilities:

- Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.

- Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.

- Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.

- Work with the project leadership to define the strategy to execute against milestones and key deliverables.

- Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team.

- Assumes accountability on the CTRA operations on specific project activities.

Requirements:

- Bachelor’s Degree, Higher Degree Preferred.

- Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.

- Experience in working to applicable GxPs (e.g., GVP, GCP (Good Clinical Practice), ISO 14155) etc.

- Subject matter expertise in current regulation frameworks.

- Strong knowledge of clinical research management processes.

- Excellent presentation, documentation, influencing, and interpersonal skills.

Benefits:

- Career development and progression

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Inclusive culture

## Skills

### Required
- CTRA
- Regulatory Affairs
- Clinical Trials
- GxP
- GCP
- ISO 14155

### Nice to have
- Spanish

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Buenos-Aires-Hybrid/Senior-Clinical-Trial-Regulatory-Advisor---Previous-experience-working-with-submissions-in-multiple-countries---Argentina_25113332?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
