Regulatory Affairs Manager CMC

ports 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 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 

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

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.