Regulatory Manager (labelling)

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

• End to End CCDS updates based on the confirmed Safety signals
• Aware of the basic process, steps, leading cross-functional discussions and CCDS approval via Safety review committees
• Updates to CCDS based on the Clinical non-clinical studies results, Abbreviated PI’s
• Management of the EU QRD’s for MRP/DCP/CP and USPI’s for Safety submissions
• Driving the labeling updates for ROW markets and artwork implementations

What you need

• 8–14 yrs of experience
• Compliance
• Regulatory affairs
• Performance management
• Customer success
• B.Sc