Sr Regulatory Consultant (CMC and Biologics)

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

• 6–9 yrs of experience
• Compliance
• Regulatory affairs
• Customer success
• B.Sc or PhD