Sr Regulatory Consultant (CMC and Biologics)
GurugramFull-timeHybrid6–9 yrsPosted 1 week ago
Senior legal role at Syneos Health in Gurugram. Needs 6–9 years and a B.Sc or PhD. Hybrid.
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
- IND- Gurugram / Hyderabad
- Strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities
- Experience handling EU and ROW CMC variation submissions
- Responsible for day-to-day contribution to project teams and projects
- Acts as a representative of the GRAS regulatory department with other departments
What you need
- Compliance
- Regulatory affairs
- Customer success