CMO Manager

Barrington James; London; Hybrid; GBP 200,000 +; Full time

Job summary

An established industry player is seeking a consultant to manage batch release compliance across a complex CMO supply chain. This role is pivotal in aligning batch release processes with Marketing Authorization Applications (MAAs) while navigating diverse regulatory landscapes across multiple global markets. The ideal candidate will have strong experience in regulatory affairs and supply chain management, with a focus on optimizing structured batch release systems. This exciting opportunity offers the chance to work in a hybrid environment, contributing to critical compliance efforts across various regions.

Qualifications

• Strong RA CMC experience managing supply chains and regulatory compliance.
• Proven ability to optimize structured batch release systems.

Responsibilities

• Develop and implement a system for batch release compliance.
• Ensure alignment with MAA variations and regulatory requirements.

Skills

Regulatory Affairs (RA)

Batch Release Compliance

Supply Chain Management

Labor Management

MMA Variations Management

Tools

Excel

Job description

MUST BE BASED IN SWITZERLAND - Hybrid, Basel (1-2 days on-site)
Full-time, 6 months, ASAP start

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)