US Regulatory Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $112.7k - $152.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Plan and execute regulatory strategies for assigned Amgen products in the United States • Align local regulatory requirements with Amgen corporate standards • Plan and manage regulatory submissions in compliance with corporate and local requirements • Provide guidance on mechanisms to optimize product development and regulatory approvals • Develop and maintain local product labels • Ensure and support regulatory product compliance, including IMR, PMCs, pediatric plans, and agency commitments • Act as point of contact with regulatory agencies and participate in agency interactions • Support global regulatory strategies, strategic plans, and labeling documents • Contribute to filing plans and execute marketing authorization and lifecycle maintenance filings • Create, review, and approve country labeling source text and own country artwork • Collaborate with Regional and Global Study Operations teams on clinical study planning and execution • Review and approve promotional and non-promotional materials • Monitor legislation, trade associations, and the external regulatory environment • Manage urgent safety communications, DHPCs, and DIL submissions • Advise global teams on local regulatory implications • Provide regulatory expertise on expedited studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans • Exchange regulatory intelligence with regulatory and cross-functional teams • Partner with International and Global Regulatory Leads • Support process improvement projects and initiatives • Oversee external vendor and contractor relationships where applicable • Conduct regulatory research • Mentor junior Local Regulatory Representatives

🎯 Requirements

• 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 • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • Understanding of drug development • Knowledge of Regulatory principles • Regulatory submissions experience and experience interacting with regulatory agencies (FDA) • Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles • Comprehensive understanding of regulatory activities and their impact on other projects and/or processes • Knowledge and experience in the US regulatory environment relevant for product area and development stage • Strong teamwork ability • Good oral and written communication skills • Good negotiation and influencing skills • Ability to understand and communicate scientific/clinical information • Ability to resolve conflicts and develop a beneficial course of action • Experience working with policies, procedures, and SOPs • Cultural awareness and sensitivity across regional, country, and international borders

🏖️ Benefits

• A comprehensive employee benefits package • 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 • Career development opportunities • Work/life balance support