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.