# Sr 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/MEX-Remote/Sr-Country-Regulatory-Specialist_25113592?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_7d9f326e-be6

## Description

Syneos Health is seeking a Sr Country Regulatory Specialist, Clinical Research to work 100% remotely in Mexico.

The successful candidate will perform assigned activities related to country regulatory operations, providing delivery and expertise in country ethics and regulatory submissions from startup until project end.

**Core Responsibilities:**

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

- Develop expert knowledge of Regulatory Authority (RA) and Ethics Committee (EC) processes, requirements, and timelines

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

- Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required

- Directly interact with RAs and ECs, 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

- Develop or support the creation of local country regulation training materials

- Support training and mentoring more junior Country Regulatory Specialists

**Qualifications:**

- Minimum of a BA or BS preferred

- 5-6 years minimum experience working in a Clinical Research environment

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

- Detailed understanding of clinical trial submission processes per-country and local regulations

- Experience in 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

- Strong presentation, documentation, influencing, and communication skills

**What We Offer:**

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
- ICH GCP
- 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/MEX-Remote/Sr-Country-Regulatory-Specialist_25113592?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)