Sr Regulatory Consultant/ Regulatory Consultant (cmc- Api - Eu Market)

Syneos Health

Multiple Locations
On-site
Module 3 cmc sections authoring
Cmc variation applications review
Api drug product variations
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success

Job Summary

  • Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • The role involves contributing technical expertise to proposals and assisting with Business Development initiatives.
  • We are committed to building an inclusive culture – where you can authentically be yourself.

Matching Summary

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.

Skills & Requirements

Must-have

  • Module 3 CMC sections authoring
  • CMC variation applications review
  • API Drug product variations
  • EU market regulatory knowledge
  • Independent issue resolution

Nice-to-have

  • Agile and driven to deliver
  • Collaborate with passionate problem solvers
  • Develop a reputation as industry leader

Key Requirements

  • Demonstrated experience in authoring and reviewing Module 3 CMC sections
  • Strong experience in review and support of CMC variation applications
  • Experience in API Drug product related variations
  • Site Transfer related experience
  • Strong organizational skills and ability to manage multiple priorities

Work Rights

Not specified

Tailored Resume

Cover Letter