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Regulatory Manager (CMC and Biologics)

HyderabadFull-timeHybrid10–18 yrsPosted 1 week ago

Leadership legal role at Syneos Health in Hyderabad. Needs 10+ 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

  • Strong expertise in Regulatory Intelligence across various global markets
  • Managed both pre-licensing and post-licensing regulatory activities
  • Familiar with market-specific regulatory requirements and change management processes
  • Open to exploring opportunities in Small Molecules in addition to Biologics and Biosimilars
  • Contributes to planning for regulatory submissions in assigned region/country/project

What you need

  • Compliance
  • Regulatory affairs
  • Documentation
  • Performance management
  • Customer success

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