Company
RegulatoryAffairsManager(CMC)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regulatory Affairs Manager (CMC). Skills: Regulatory Affairs (CMC), Regulatory Strategy, Dossier Development, Health Authority Interactions. Execution and/or coordination of global regulatory CMC activities. Providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products”
Industry & Context.
Regulatory risk assessments; Responding to health authority questions
What They're Looking For.
Must Have
CMC- specific regulatory knowledge & experience, 3 years of directly related experience (with Master's degree), 5 years of directly related experience (with Bachelor's degree), Experience in manufacture, testing (QC/QA or clinical), or distribution, Regulatory CMC experience
What You'll Do.
Execution and/or coordination of global regulatory CMC activities
and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products
Communicating the regulatory strategy
risks and issues to Regulatory and Operations senior management
Coordinating communication
and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities
Contributing to product teams and acting as product lead or principal for one or more products
Providing strategic regulatory input and regulatory risk assessments for product
Executing regulatory strategy with respect to preparation of regulatory filings
Identifying need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy
Reporting needs for process changes to CMC systems
Contributing to process improvements
Incorporating changes in external regulatory guidance into CMC strategy and guidance for product
Reporting issues to RA CMC product team management
Generating and executing of global and country-specific regulatory strategies
Providing CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements
and regulatory risk assessments
Developing global dossiers for CMC content for initial submissions
variations and amendments
Supporting change management activities
Developing response strategy and responding to health authority questions
Liaising with other functions in development
operations and commercial to ensure alignment of global regulatory strategies
execution and supply plans
Liaising with local regulatory teams to align on filing strategy
providing data to be entered into tracking systems for department deliverables and ensuring information is current
Maintaining submission information according to the Regulatory Information Management (RIM) system
Following established department regulatory processes to ensure cross-product alignment
How You'll Work.
Team & Collaboration
Contributes to product teams; Coordinates communication, collaboration, and coordination with the site and regional CMC representatives; Liaises with other functions in development, operations and commercial; Liaises with local regulatory teams
Communication Scope
Communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management; Coordinates communication; Communicating regulatory strategy
Process & Methodology
Oversee the successful execution and implementation of the regulatory strategy, Develop and execute global regulatory activities, Acts as product lead or principal for one or more products, Manage submission information
Full Job Description
## **Career Category** Regulatory ## ## **Job Description** 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. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. **Key Activities** Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management. **Key Responsibilities Include:** * 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 * Develop response strategy and respond to health authority questions * Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution
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