# Country Regulatory Specialist, Clinical Research

**Company**: Syneos Health
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/Country-Regulatory-Specialist--Clinical-Research---100--Remote-in-Brazil--English-advanced_25113591?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_436e88d4-87b

## Description

Syneos Health is seeking a Country Regulatory Specialist, Clinical Research to work 100% remotely in Brazil. The successful candidate will have advanced English language skills.

The role involves performing assigned activities related to country regulatory operations, providing delivery and expertise in country ethics and regulatory submissions from startup until project end. The ideal candidate will have experience working in a Clinical Research environment, preferably in the regulatory area, and a detailed understanding of clinical trial processes and submission processes per-country and local regulations.

**Responsibilities**

- Provide quality deliverables at the country and site level, following project requirements and applicable country rules

- Maintain expert knowledge of Regulatory Authority and Ethics Committee processes, requirements, and timelines

- Provide country-level SME knowledge at the pre-award stage to support robust business development presentations

- Prepare and submit regulatory applications, including Central EC Applications, Local EC Applications, and RA Applications

- Interact with Regulatory Authorities and Ethics Committees, identifying solutions when issues arise

- Serve as the country-level regulatory SME point of contact through the life of assigned projects

- Ensure all relevant documents are submitted to the Trial Master File (TMF) in compliance with SOPs and Customer requirements

**Requirements**

- Minimum of a BA or BS degree

- 3-4 years of experience working in a Clinical Research environment, or an equivalent combination of education and experience

- Detailed understanding of clinical trial process across Phases I-IV and ICH GCP

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

- Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality

- 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
- Clinical Research
- Regulatory Affairs
- Ethics Committee
- Regulatory Authority
- GxP
- Microsoft Office Suite

---

Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/Country-Regulatory-Specialist--Clinical-Research---100--Remote-in-Brazil--English-advanced_25113591?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)