Senior Associate, Regulatory Affairs – CMC

Amgen

Senior Associate in Regulatory Affairs developing strategies for product registration and quality programs. Collaborating with global teams to support product development and regulatory submissions in biotech.

Posted 6/29/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $83,974 - $113,613 per yearWebsite

About the role

Key responsibilities & impact

Facilitate product development and global registration by developing and executing regulatory strategies
Manage effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle
Contribute as a member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post-market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

Requirements

What you’ll need

Master’s degree OR Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR Associate’s degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience
BS degree in life science
Experience in manufacture, process development, quality assurance, quality control, or analytical development
Regulatory CMC specific knowledge and experience
Developed project management and organizational skills
Strong and effective oral and written communication skills.

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
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
Flexible work models where possible.

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Hard Skills & Tools

Regulatory Strategy DevelopmentCMC Submission PreparationDocument ManagementProduct Lifecycle ManagementQuality ControlAnalytical DevelopmentProcess DevelopmentManufacturing ExperienceInvestigational Product AmendmentsPost-Market Supplements

Soft Skills

Organizational SkillsEffective Communication