Amgen Global Regulatory and R&D Policy Director in Washington, District Of Columbia
Global Regulatory and R&D Policy team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging regulators, industry and professional associations, patient advocates, and internal subject matter experts across Amgen.
The team leads and/or participates in developing, advocating for, and implementing Amgen's positions on regulatory policies that impact Amgen's business. The team works with cross-functional colleagues to develop strategic policy plans to advance regulatory policy issues and engages regulatory authorities, industry, and professional associations on policy issues.
Additional responsibilities of the Global Regulatory and R&D Policy Director:
Provide strategic regulatory and R&D policy advice and guidance related to Amgen’s oncology portfolio
Lead and/or participate in developing and successfully advancing Amgen's regulatory, safety, and R&D policy positions, with an emphasis on Amgen’s oncology portfolio
Assist and advise executive leadership on regulatory and R&D policy issues related to the oncology portfolio, including establishing priorities, and developing and executing regulatory policy advocacy plans
Foster a reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies
Leverage understanding of regulatory health authorities (e.g. FDA, EMA, national competent authorities), industry trade associations, and other relevant organizations, to advance Amgen's position related to regulatory and safety policy, with an emphasis on oncology issues
Provide internal stakeholders (e.g., Value and Access, Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory and safety policy perspective on key issues
Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to Amgen’s policy strategy, with an emphasis on oncology
Doctorate degree and 4 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience
Master’s degree and 8 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience
Bachelor’s degree and 10 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience in building relationships with industry stakeholders (e.g., trade associations, biopharmaceutical companies, FDA, EMA, other national competent authorities)
Proven strategic and analytical abilities
Knowledge of Regulatory, R&D, and Safety drug development issues, including a strong background in oncology issues
Experience in policy development
Strong presentation and interpersonal communication skills
Experience in Staff Management and Talent Development
Comprehensive knowledge of the biopharmaceutical industry, including development and execution of regulatory policy strategic plans
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.