Amgen Director Global Regulatory and R&D Policy in Washington, District Of Columbia
Amgen is seeking a Director of Global Regulatory and R&D Policy who will report to an Executive Director of Regulatory Affairs. This position can be located in our Washington, D.C. location or our Thousand Oaks, CA location.
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.
The responsibilities of the Director Global Regulatory and R&D Policy:
Provide oversight and strategic direction to policy staff on US policy issues
Lead and/or participate in developing and successfully advancing Amgen's regulatory, safety, and R&D policy positions
Assist and advise executive leadership on policy issues, 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
Provide internal stakeholders (e.g., 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
Doctorate degree and 4 years working in a Pharmaceutical or Biotech industry with Regulatory/Policy or Legal experience
Master's degree and 8 years working in a Pharmaceutical or Biotech industry with Regulatory/Policy or Legal experience
Bachelor's degree and 10 years working in a Pharmaceutical or Biotech industry 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
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 is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.