Senior Manager, U.S. Regulatory Strategy – Obesity and Related Conditions

🔥 19 minutes ago

🇺🇸 United States – Remote

💵 $149.4k - $202.1k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

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

• Support products in the Obesity and Related Conditions Therapeutic Area • Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL) • Represent the U.S. on global teams and contribute to global regulatory and clinical development strategies • Plan and lead U.S. regulatory submissions in alignment with global filing plans and regulatory requirements • Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy • Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group • Lead Health Authority interactions for assigned products • Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management. • Ensure ongoing compliance for assigned products and proactively escalate issues

🎯 Requirements

• Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and 8 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • Experience supporting or leading regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas. • Strong scientific literacy in obesity and metabolic disease, including metabolic pathways, weight regulation biology, and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers). • Experience leading U.S. labeling strategy, including negotiation and timeline management in a cross-functional environment. • Experience working with policies, procedures, and SOPs in a regulated environment.

🏖️ 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.