CMC Regulatory Strategy Lead - Post-Market

Amgen Inc.; United States; Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health benefits package

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off

Flexible work models

Job summary

Amgen Inc. is seeking a Regulatory Affairs Manager - CMC in the United States. In this vital role, you will strategize and execute site-specific CMC regulatory activities, coordinating with global teams to ensure compliant filings for post-market supplements and facility registrations.

You will provide regulatory inputs and assess deviations to shape strategy. You will drive regulatory submissions, develop post-approval variations, and ensure ongoing compliance through appropriate filings, with

Qualifications

• Doctorate or equivalent in a life sciences field with regulatory science focus.
• Experience in regulatory CMC within pharma/biotech.
• Knowledge of ICH guidelines and GMP/GCP requirements.
• Experience preparing regulatory dossiers per CTD structure.
• Strong regulatory strategy and post-market submission skills.

Responsibilities

• Define regulatory filing requirements for postapproval programs.
• Develop regulatory strategy via MASP and/or GIRS.
• Develop post-approval variations and maintain applications.
• Coordinate with site functions for regulatory filings and deviations.
• Provide impact assessments with input from CMC teams and regional reps.
• Support Change Management activities as needed.
• Respond to agency questions and prepare briefing documents.
• Collaborate with cross-functional teams to align global regulatory strategies.

Skills

Regulatory strategy

CMC regulatory affairs

Cross-functional collaboration

Regulatory submissions

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen Inc. is seeking a Regulatory Affairs Manager - CMC in the United States. In this vital role, you will strategize and execute site-specific CMC regulatory activities, coordinating with global teams to ensure compliant filings for post-market supplements and facility registrations.

You will provide regulatory inputs and assess deviations to shape strategy. You will drive regulatory submissions, develop post-approval variations, and ensure ongoing compliance through appropriate filings, with