Global Regulatory Policy and Intelligence Director

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Amgen

WebsiteLinkedInAll Job Openings

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

Description

• Join Amgen’s Mission of Serving Patients • The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities • Key Responsibilities: • Masters a range of regulatory policy topics and provides strategic regulatory policy advice and guidance related to Amgen’s product portfolio • Monitors, analyzes, and anticipates changes in the regulatory environment • Develops and successfully advances Amgen's regulatory, safety, and R&D policy positions • Engages with US regulatory authorities, industry, and professional association leaders at the policy level • Cultivates internal cross-functional partnerships and provides partners with a strategic regulatory policy perspective • Promotes internal awareness of key regulatory policy changes and coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions

Requirements

• Basic Qualifications: • Doctorate degree and 4 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience • Or Master’s degree and 7 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience • Or Bachelor’s degree and 9 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience • Preferred Qualifications: • Experience in regulatory policy development with comprehensive knowledge of biopharmaceutical industry • Experience in building relationships with key stakeholders (e.g., trade associations, biopharmaceutical companies, FDA, etc.) • Knowledge and use of regulatory intelligence tools to monitor, analyze, and anticipate changes in the regulatory environment • Strong presentation and interpersonal communication skills • Proven strategic and analytical abilities

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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible