Amgen

US Regulatory Lead

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $112,744 - $152,536 per year

Job Level

Senior

About the role

  • Join Amgen’s Mission of Serving Patients.
  • Provide local input to and execute regulatory strategies.
  • Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
  • Manage the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements.
  • Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).

Requirements

  • Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience
  • Knowledge of Regulatory principles.
  • In-depth regulatory experience in the applicable country(ies).
  • In-depth knowledge of country(ies) legislation and regulations relating to medicinal products.
  • Working with policies, procedures, and SOP’s.
  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
  • General knowledge of national legislation and regulations relating to medicinal products.
  • General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
  • Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
  • Understanding of drug development.
  • Good communication skills - both oral and written.
  • Good negotiation and Influencing skills.
Benefits
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • 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
  • 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 strategiesregulatory submissionslocal legislationsafety communicationsclinical studiesregulatory principlesdrug developmentregistration procedureslifecycle managementregulatory environment
Soft Skills
communication skillsnegotiation skillsinfluencing skills
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED