Amgen

Regulatory Professional – Obesity and Related Conditions

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $88,347 - $110,633 per year

About the role

  • Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements
  • Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time
  • Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications
  • Create and maintain product regulatory history documentation (e.g., IMR, as applicable)
  • Support U.S. labeling activities, including review of source text to enable U.S. labeling updates
  • Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements
  • Coordinate and QC briefing documents and other materials for meetings with regulatory agencies
  • Under general supervision, support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations
  • Support responses to health authority questions by coordinating inputs, tracking actions, and ensuring document readiness
  • Collate and communicate regulatory information across regulatory colleagues and cross-functional teams; provide timely updates on U.S.-specific considerations
  • Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; escalate and disseminate relevant updates to appropriate stakeholders
  • Participate in cross-functional and team governance (e.g., GRT support including agendas/minutes) as needed.

Requirements

  • Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum OR Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience OR Associate’s degree in a science discipline (biology, life science, health science) and 6 years of directly related experience OR High school diploma / GED in a science discipline (biology, life science, health science) and 8 years of directly related experience
  • Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare)
  • Experience supporting programs in Obesity, Diabetes, or related metabolic diseases through scientific or clinical work
  • Strong written and oral communication skills
  • Strong organizational skills; ability to manage multiple activities, timelines, and stakeholders
  • Demonstrated attention to detail and document quality mindset
  • Ability to identify, communicate, and escalate risks/issues appropriately
  • Experience with document management and archiving practices in a regulated setting.
Benefits
  • A comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsregulatory documentationU.S. labeling activitiesdocument managementarchiving practicessubmission readinessquality controlFDA interactionshealth authority responsesbiological curriculum
Soft Skills
written communicationoral communicationorganizational skillsattention to detailrisk identificationstakeholder managementtimelinesscross-functional collaborationdocument quality mindsetescalation of issues
Certifications
Master’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED