# Clinical Trial Regulatory Advisor

**Company**: Syneos Health
**Location**: ARG-Remote
**Work arrangement**: remote
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Remote/Clinical-Trial-Regulatory-Advisor---The-position-is-to-work-with-submissions-in-Canada---Argentina-Home-Based_25113414?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0f5408f7-a2c

## Description

We are seeking a Clinical Trial Regulatory Advisor to work with submissions in Canada and Argentina. As a Clinical Trial Regulatory Advisor, you will provide regulatory and technical support for assigned regulatory work, including review and finalization of essential core documents required for site initiation regulatory and core submissions.

Responsibilities:

- Perform CTRA operations deliveries on specific project activities, including regulatory leading function, resulting in client satisfaction

- Review clinical trial study core documents, such as labelling for regulatory compliance

- Contribute to and prepare technical components of regulatory core submissions, such as EU Clinical Trial Regulation Part I and/or II

- Manage and operationalize day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies

- Act as a subject matter expert and help team members with day-to-day troubleshooting activities, presenting solutions to project-related problems

- Participate as regulatory support on multidisciplinary project teams to develop products throughout their life cycle

- Identify and report on areas of process and risk

Qualifications:

- Minimum of a BA or BS preferred

- Experience working to applicable GxPs (e.g., GVP, GCP, ISO 14155)

- Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken English)

- Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, email, and internet

Benefits: Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

## Skills

### Required
- GxP
- regulatory compliance
- clinical trials
- Microsoft Office Suite

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Remote/Clinical-Trial-Regulatory-Advisor---The-position-is-to-work-with-submissions-in-Canada---Argentina-Home-Based_25113414?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)