Regulatory Manager (labelling)
HyderabadFull-timeHybrid8–14 yrsPosted 1 week ago
Leadership legal role at Syneos Health in Hyderabad. Needs 8+ years and a B.Sc. 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
- 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
- Compliance
- Regulatory affairs
- Performance management
- Customer success