openfractionalOncologySmall molecule

Regulatory CMC Lead — BLA prep

Helix Bio· posted 3 days ago

About this engagement

BLA submission planned for Q4. Need a regulatory CMC lead to author Module 3 sections, manage CDMO doc requests, and represent us in pre-BLA meeting prep.

Required capabilities

Module 3 authorshipBLA prepPre-BLA meeting

Nice to have

FDA experienceCDMO doc management

About the sponsor

Helix Bio is a biotech working in Oncology. They've engaged 4 advisors via LynQX in the last 12 months with a 92% renewal rate.

This engagement is part of campaign: Helix Bio · Phase 2 Oncology Team Build.

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