Regulatory Affairs Specialist

4 settimane fa


Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

We are seeking a talented Regulatory Affairs Scientist to join our team at Eli Lilly. As a key member of the CMC Regulatory team, you will be responsible for drug registration activities within the production facility and contract manufacturers.

Main responsibilities:

  • Provide regulatory support for products/contract manufacturers and projects as required.
  • Lead the preparation, review, and finalization of CMC documents for global regulatory submissions.
  • Develop global CMC regulatory strategies in collaboration with other regulatory, MS&T, Quality, and project personnel.
  • Ensure that all changes and deviations are reviewed and that any required regulatory activity is carried out prior to implementation.
  • Identify and escalate CMC regulatory issues impacting product submissions across geographies.
  • Provide regulatory guidance to Global Post Launch Optimization Teams, Change Control Boards, and Technical forums.
  • Ensure that all applicable GMP documents are in compliance with current regulatory commitments.

Required qualifications:

  • Master's degree in a scientific field (CTF, Biology, Chemistry)
  • Excellent command of the English language
  • Demonstrated CMC Regulatory knowledge/experience, including EU/US and ICH guidelines
  • Excellent communication skills and ability to influence
  • Willingness to travel as requested
  • Appreciation of cultural diversity
  • Attention to detail.

Lilly is an equal opportunities employer and welcomes applications from all qualified candidates.



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