Regulatory Affairs Manager – Oncology

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $112.7k - $152.5k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 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

• Formulate and communicate the regulatory promotional position for approved and/or pipeline Oncology products and disease state • Provide strategic direction for product and disease communications and associated activities • Interpret the current regulatory environment to ensure truthful and non-misleading communication to the health care community, patients, and the public • Serve as a regulatory advertising and promotion lead for approved and/or pipeline Oncology products and disease state • Ensure deliverables are consistent with the product label, compliant with US FDA regulations and guidance, and adhere to Amgen SOPs and policies • Identify opportunities and challenges impacting US product strategy based on evolving competition, regulatory environment, and clinical data • Evaluate appropriate levels of evidence to make product claims • Mentor Manager-level promotional reviewers

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of industry experience OR Bachelor’s degree and 4 years of industry experience OR Associate’s degree and 8 years of industry experience OR High school diploma / GED and 10 years of industry experience • 2 years experience in Oncology • Experience in interpretation of government regulations, policies, and guidance • Strong clinical data analysis skills • Ability to use judgement and data to formulate and communicate positions on complex issues • Experience collaborating within large cross-functional teams

🏖️ 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, and flexible spending accounts • A 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 • Sponsorship for this role is not guaranteed