Regulatory Labeling Manager

October 28

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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

• The Regulatory Labeling Manager is responsible for managing the end-to-end labeling processes for pre- & post-marketed products • Authoring and maintaining core company labeling documents • Leading the cross-functional Labeling team • Authoring US labeling documents • Presenting to cross-functional and executive level management • Providing strategic guidance on labeling regulations and requirements • Supporting preparation of responses to labeling-related Health Authority queries • Managing review and approval of core DHCP letters

Requirements

• Doctorate degree • Or Master’s degree and 2 years of related experience • Or Bachelor’s degree and 4 years of related experience • Or Associate’s degree and 8 years of related experience • Or High school diploma / GED and 10 years of related experience • Preferred Qualifications: • Demonstrated experience in authoring, developing, and updating Pharmaceutical or Biotechnology product prescribing information labeling • Degree in pharmaceuticals, life science or medicine • Knowledge of prescribing information labeling development within various Therapeutic Areas • Knowledge of FDA, or EMA, or other international regulations for prescribing information labeling with understanding the impact of emerging trends and their implications for Amgen • Project Management experience, experience managing individual and group projects of moderate complexity • Strong collaboration, presentation, communication, interpersonal, and leadership skills • Experience working in a Veeva-based RIM Regulatory Management system

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