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).

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.

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.

US Regulatory Lead

Key skills