Senior Associate US Regulatory Affairs

2 weeks ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Associate US Regulatory Affairs

Live

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 US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications (BLAs) and New Drug Applications (NDAs); advisory committee meeting preparations)
  • Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
  • Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
  • Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
  • Actively support regulatory compliance and ensure compliance of submissions to the US FDA
  • Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
  • Coordinate collection of functional documents in support of regulatory applications
  • Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
  • Assist the USRL in managing the process for responding to FDA questions
  • Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies
  • Complete regulatory forms to support agency communications (e.g. FDA form 1571)
  • 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
  • Support the development and execution of GRT goals

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a partner with these qualifications.

    Basic Qualifications:

    • Masters degree OR
    • Bachelors degree and 2 years of regulatory or pharmaceutical experience OR
    • Associates degree and 6 years of regulatory or pharmaceutical experience Or
    • High school diploma / GED and 8 years of regulatory or pharmaceutical experience

      Preferred Qualifications:

    • Strong communication skills oral and written
  • Organizational skills
Regulated industry, science or clinical practice experience

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

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

Equal Opportunity Statement

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 a 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 an accommodation.

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