Regulatory Affairs Manager –Combination Products

Amgen SA; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager to drive regulatory strategies for innovative drug delivery devices. In this impactful role, you will lead health agency engagements, support regulatory compliance, and develop strategic plans that ensure successful product launches. With a commitment to patient care, this company fosters an environment that promotes professional growth and work-life balance. Join a team dedicated to making a difference in the lives of millions while enjoying comprehensive benefits and flexible work arrangements. This is your chance to shape the future of healthcare and elevate your career in a meaningful way.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Bi-annual company-wide shutdowns

Qualifications

• Doctorate or Master's with 3 years in regulatory affairs required.
• Strong project management and communication skills essential.

Responsibilities

• Support regulatory strategies and filings for drug delivery devices.
• Lead health agency engagements and filing activities.

Skills

Regulatory Affairs

Project Management

Communication Skills

Device Design Controls

Regulatory Compliance

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associates degree

High school diploma / GED

Tools

Veeva Vault

Job description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager – Combination Products

What you will do

In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.

• Support the development, communication, implementation, and maintenance of regulatory strategic plans
• Lead and/or support health agency engagements
• Lead and/or support filing activities and associated health agency inquiries
• Support device design controls activities and documentation reviews
• Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions
• Perform change control regulatory assessments
• Develop and support implementation and maintenance of internal regulatory processes
• Perform device determination decisions for regulated items
• Support supplier engagement teams and due diligence activities
• Review regulatory sections in development, quality, and supply agreements
• Support regulatory compliance initiatives

What we expect of you

The Regulatory professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 3 years of pharma/biotech and/or medical device and combination products regulatory affairs experience
• OR
• Bachelor’s degree and 8 years of pharma/biotech and/or medical device and combination products regulatory affairs experience; OR
• Associates degree and 10 years of pharma/biotech and/or medical device and combination products regulatory affairs experience; OR
• High school diploma / GED and 12 years of pharma/biotech and/or medical device and combination products regulatory affairs experience;

Preferred Qualifications:

• Master’s degree in regulatory affairs, engineering, or life sciences
• 6 or more years of experience in medical device and combination products regulatory affairs
• Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development
• Experience in drug delivery device or diagnostics device regulatory submission process
• Regulatory CMC specific knowledge and experience
• Mature project management and organizational skills
• Strong and effective oral and written communication skills
• Experience in Veeva Vault platforms

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

Join us.

careers.amgen.com

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.