United States Regulatory Manager – Obesity And Related Conditions

Amgen

Remote
Base: 112,744.00usd - 152,536.00 usd; bonus/equity...
U.s. regulatory strategy and tactics
U.s. regulatory submissions
Regulatory compliance and patient safety
Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions Therapeutic Area

Job Summary

  • Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions Therapeutic Area.
  • In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen standards—with a strong focus on regulatory compliance and patient safety.
  • Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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.

Matching Summary

Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions Therapeutic Area.

Salary

Base: 112,744.00USD - 152,536.00 USD; Bonus/Equity: discretionary annual bonus program, stock-based long-term incentives; Benefits: comprehensive employee benefits package, Retirement and Savings Plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts

Skills & Requirements

Must-have

  • U.S. regulatory strategy and tactics
  • U.S. regulatory submissions
  • regulatory compliance and patient safety
  • Health Authority interactions
  • drug development and registration pathway

Nice-to-have

  • collaborative, innovative, and science based culture
  • passion for challenges
  • transforming lives of patients
  • cultural awareness and global operations

Key Requirements

  • Doctorate degree OR Master’s degree and 2 years of directly related experience
  • Bachelor’s degree and 4 years of directly related experience
  • Associate’s degree and 8 years of directly related experience
  • High school diploma / GED and 10 years of directly related experience
  • Regulatory submissions experience
  • Interacting with regulatory agencies (FDA)
  • Working knowledge of U.S. legislation/regulations
  • Experience supporting regulatory strategy for obesity programs

Work Rights

Not specified

Tailored Resume

Cover Letter