Regulatory Affairs CMC Sr. Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Regulatory Affairs CMC Senior Manager

Live

What you will do

The CMC Regulatory Senior 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 CMC Regulatory Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Regulatory Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The CMC Regulatory Senior Manager may have staff oversite.

Key Activities

Contributes to product teams and acts as Global CMC Regulatory lead 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 CMC Regulatory 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 CMC Regulatory product team management. May manage and develop junior staff.

Key Responsibilities Include:

• Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,
• Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally
• Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
• Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff
• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
• 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

Knowledge and Skills

Regulatory CMC- specific regulatory knowledge & experience

Staff management and development

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.