Regulatory Affairs Director - Global Regulatory Lead

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

• Lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization • Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development • Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance • Represent Regulatory on the product team • Ensure consistency of evidence-based global product communication • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

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 and build 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 • Due Diligence 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