Associate Director, Regulatory Policy and Intelligence

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $155.4k - $210.2k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Lead development and articulation of Amgen’s positions on regulatory policies affecting its business portfolio • Foster U.S. trade association relationships and steward regulatory and R&D-related trade association engagements • Staff company executives in leadership roles in domestic and international forums • Develop and lead enterprise-wide regulatory reform initiatives • Implement strategies to shape policy outcomes and the external environment • Identify related internal business needs for policy implementation • Lead assigned policy initiatives from analysis and position development through external engagement and implementation • Partner with Government Affairs, R&D, Operations, and other stakeholders to develop advocacy materials • Prepare presentations and communications to align positions and strategies across Amgen organizations and regions • Investigate policy research questions and assess implications of emerging regulatory developments • Analyze regulatory guidances and policy documents to inform positions and impact assessments • Plan and help manage projects for agreed policy objectives • Report to Amgen’s U.S. Lead for Regulatory Policy and Intelligence

🎯 Requirements

• Doctorate degree or 3 years of regulatory experience • Master’s degree and 5 years of related experience • Bachelor’s degree and 7 years of regulatory experience • Associate’s degree and 12 years of regulatory experience • High school diploma / GED and 14 years of regulatory experience • In-depth knowledge and demonstrated policy leadership with U.S. legislation and regulations relating to medicinal products • Trade association or consortia experience • Strong oral and written communication skills • Strong interpersonal, problem solving, and conflict resolution skills • Ability to work collaboratively across functional areas • Ability to work well with people at all levels in demanding situations • Ability to work in a fast-paced environment with high attention to detail and quality • Excellent organization, process, and project management skills • Sponsorship for this role is not guaranteed

🏖️ 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 • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support

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