US Regulatory Lead

Join Amgen's Mission of Serving Patients

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech, focusing on Oncology, Inflammation, General Medicine, and Rare Disease.

What you will do

US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

• Assist in aligning local regulatory requirements with Amgen's corporate standards.
• Provide local input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards.
• Ensure and support local regulatory product compliance (e.g., IMR, PMCs, agency commitments).
• Act as the point of contact with regulatory agencies.
• Support and provide input into the global regulatory strategy for assigned products.

Strategic and Execution

• Contribute to and execute the filing plan (MA and lifecycle maintenance).
• Ensure regulatory submissions are timely and meet corporate and local requirements.
• Create, review, and approve source text for country labeling; own country artwork.
• Collaborate with Global Study Operations teams on clinical study planning and execution.
• Review and approve promotional and non-promotional materials.
• Monitor changes in national legislation and the external regulatory environment.
• Manage submission of urgent safety communications, DHPCs & DILs as required.
• As part of the Global Regulatory Team, provide expertise on expedited pathways, Orphan Drug Designations, compassionate use, and pediatric plans.

Health Authority Interactions

• Act as point of contact with regulatory agencies in fulfilling local obligations.
• Participate in and prepare for agency interactions.

Communication and Collaboration

• Work closely with cross-functional colleagues to align on strategy and deliver goals.
• Partner with International Regulatory Leads and Global Regulatory Leads.
• Provide SME support to process improvement initiatives.

Country Specific Activities

• Assist in Healthcare Compliance, QA or pharmacovigilance activities where applicable.
• Oversee external vendor/contractor relationships where applicable.

Regulatory Research

• Maintain awareness of new legislation, regulatory policy and guidance.
• Perform regulatory research on histories and precedence.

Mentoring

• Mentor and advise junior Local Regulatory Representatives.

What we expect of you

Basic Qualifications

• Doctorate degree; OR
• Master's degree and 3 years of US Regulatory experience; OR
• Bachelor's degree and 5 years of US Regulatory experience; OR
• Associate's degree and 10 years of US Regulatory experience; OR
• High school diploma / GED and 12 years US Regulatory experience

In addition, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

• Understanding of drug development and regulatory principles.
• Regulatory submissions experience and experience interacting with FDA.
• Working knowledge of U.S. legislation/regulations relating to medicinal products.
• Strong teamwork, communication, negotiation and influencing skills.
• Ability to understand and communicate scientific/clinical information.
• Working with policies, procedures, and SOPs.

What you can expect from us

Expected annual salary range (U.S., excluding Puerto Rico): $112,744 – $152,536 USD. Amgen offers a Total Rewards Plan including:

• Retirement and Savings Plan with generous company contributions; 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

Amgen does not have an application deadline for this position. Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.