HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.Senior Associate Regulatory AffairsLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
Assist U.S. Regulatory Lead to support regional regulatory activities
Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory Lead
Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
Review regional component of the Global Regulatory Plan and provide input to operational deliverables
Ensure compliance with submissions to regulatory agencies
Support U.S. Regulatory Lead in review of HA interaction activities
Collaborate with CRO’s / partners to support site initiation, as applicable
Coordinate collection of functional documents in support of regulatory applications
As appropriate participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing packages)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Approve drug shipment for Amgen and Investigator Initiated Studies
Complete regulatory forms to support agency communications
Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
Support process improvement initiatives, standards development, and metrics
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Develop Regulatory Position with teams
Actively support regulatory compliance
Support the development and execution of GRT goals
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a partner with these qualifications.Basic Qualifications:Master’s degreeOrBachelor’s degree & 2 years of Regulatory experienceOrAssociates degree & 6 years of Regulatory experienceOrHigh school diploma / GED & 8 years of Regulatory experiencePreferred Qualifications:
Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
Regulated industry, science or clinical practice experience
Timeline management
Strong communication skills - oral and written
Organizational skills
Ad hoc meeting support
Agendas, minutes
ThriveWhat you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineAmgen 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.
