CMO Manager

We are recruiting a consultant to manage batch release compliance across a complex CMO supply chain. The role will focus on aligning batch release processes with Marketing Authorization Applications (MAAs), while navigating diverse regulatory landscapes across EU, US, Russia, Asia, LATAM, Canada, and the Middle East.

Key Responsibilities:

1. Develop and implement a system for batch release compliance (transitioning from Excel)
2. Ensure alignment with MAA variations and regulatory requirements for multiple global markets
3. Collaborate/manage CMOs and CLOs to mitigate regulatory challenges
4. Strong understanding and experience with labor management

Requirements:

1. Strong RA CMC experience with demonstrated success in managing supply chains and regulatory compliance for batch releases
2. Skilled in managing MAA variations and regulatory updates in line with a complex supply chain
3. Proven ability to optimize/implement structured batch release systems
4. Ability to work in a virtual manufacturing model (all manufacturing outsourced)