Career Category

Regulatory

Job Description

Job Summary

The RA CMC Product Lead is responsible for execution and/ or coordination of all 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 Product Lead is member of the product team, the Global Operations Team, Global Regulatory Team and is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and coordination with the site and regional CMC representatives on the CMC GRT to develop and execute global regulatory activities.

Key Activities

Contributes to product teams and acts as product lead for one or more  commercial 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 post-approval variation an existing CTAs for marketed products
• Develop post-approval submissions including maintenance of commercial and clinical applications globally
• 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 and supply plans
• Liaise with local regulatory teams to align on filing strategy
• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
• Follow established department regulatory processes to ensure cross-product alignment
• Participate as an active member of cross-fucntional teams including Global Regulatory, Operations and Quality as needed

Knowledge and Skills

CMC- specific regulatory knowledge & experience

Basic Qualifications

Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience
OR
Associate’s degree and10 years of directly related experience
OR
High school diploma / GED and12 years of directly related experience

Preferred Qualifications

Experience in manufacture, testing (QC/QA or clinical), or distribution

Regulatory CMC experience

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

104,616.00 USD - 134,871.00 USD