Regulatory Publishing Specialist (arg & Serbia Only)
Syneos Health
Argentina
Electronic publishing of regulatory submissions
Document assembly and submission preparation
Knowledge of ectd format and publishing systems
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success
Job Summary
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
The role involves preparing and assembling regulatory submissions using various electronic publishing tools and ensuring compliance with defined processes.
The company is committed to career development, an inclusive culture, and delivering impactful healthcare solutions.
Matching Summary
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
Skills & Requirements
Must-have
electronic publishing of regulatory submissions
document assembly and submission preparation
knowledge of eCTD format and publishing systems
regulatory data migration and reporting
quality control of published documents
Nice-to-have
knowledge of ICH guidelines and regulations
experience with multiple regulatory markets
strong communication and organizational skills
ability to multitask across projects
inclusive and supportive team culture
Key Requirements
located in Argentina or Serbia
moderate regulatory environment experience
experience with Extedo’s eCTDManager and related software
knowledge of medical/scientific terminology
understanding of submission requirements for USFDA and EMA
Work Rights
Must be located in Argentina or Serbia with no sponsorship needs