Regulatory Affairs Manager (CMC)

About the role

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management.

What you'll do

• Responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management
• Generate and execute of global and country-specific regulatory strategies
• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
• Develop global dossiers for CMC content for initial submissions, variations and amendments
• Support change management activities

What you need

• Regulatory affairs
• Communication
• Any graduate