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

Basic Qualifications

Doctorate degree and 4 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

OR

Master's degree and 8 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

OR

Bachelor's degree and 10 years working in a Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • 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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.