Regulatory Consultant (CMC-EU, GCC & AU)
RemoteFull-timeJunior levelPosted over a month ago
Legal role at Syneos Health. Remote.
About the role
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
What you'll do
- CMC authoring exposure, authored CTD Module 3 (M3) sections independently
- Anyone only compiling/reviewing documents will not fit
- Cross-functional interaction with analytical, formulation and manufacturing teams
- CMC writing and lifecycle management for small molecules
- Writes content from raw CMC documents
What you need
- Compliance
- Regulatory affairs
- SOP writing
- Documentation
- Customer success