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Senior Associate Regulatory Affairs

2 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 AffairsLive

What you will do

Lets do this. Lets 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 CROs / 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 goalsWin

    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 partner with these qualifications.Basic Qualifications:

    Masters degreeOr

    Bachelors degree & 2 years of Regulatory experienceOr

    Associates degree & 6 years of Regulatory experienceOr

    High school diploma / GED & 8 years of Regulatory experiencePreferred Qualifications:

  • Masters degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
Regulated industry, science or clinical practice experienceTimeline managementStrong communication skills - oral and writtenOrganizational skillsAd hoc meeting supportAgendas, minutesThrive

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

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