Regulatory Affairs Manager –Combination Products

Career Category

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

Let’s do this. Let’s change the world. 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

We are all different, yet we all use our unique contributions to serve patients. 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

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.

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

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.