Regulatory Affairs Director - Global Regulatory Leader

November 6

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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 • Our shared mission—to serve patients living with serious illnesses—drives all that we do. • Help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines. • Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements. • Lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. • Ensure consistency of evidence-based global product communication. • Communicate consistently well defined, successful regulatory strategies throughout the organization.

Requirements

• Doctorate degree and 4 years of regulatory experience in biotech or science • Or Master’s degree and 7 years of regulatory experience in biotech or science • Or Bachelor’s degree and 9 years of regulatory experience in biotech or science • Ability to lead effective teams • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against future strategic issues & uncertainties • Ability to resolve conflicts and develop a course of action • Cultural awareness and sensitivity to achieve global results • Planning and organizing abilities • Able to prioritize and manage multiple activities • Ability to make complex decisions and solve problems • Ability to deal with ambiguity • Negotiation skills • Global Regulatory Affairs experience • Biological product experience • Early and late stage development experience

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, including remote and hybrid work arrangements, where possible