The 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 authorities across Amgen.
Amgen is seeking a Global Regulatory and R&D Policy Director to work out of our Thousand Oaks, CA or Washington, D.C. office.
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 position include:
+ Providing strategic regulatory and R&D policy advice and mentorship on a range of issues related to Amgen’s product portfolio
+ Leading and/or participating in developing and successfully advancing Amgen’s regulatory, safety, and R&D policy positions
+ Assisting and advising executive leadership on regulatory and R&D policy issues, including establishing priorities, and developing and executing regulatory policy advocacy plans
+ Cultivating a reputation with regulators as being science-based, reliable, and credible by advocating for sound regulatory policies
+ Demonstrating understanding of regulatory health authorities (e.g. FDA, EMA), industry trade associations, and other relevant organizations, to advance Amgen’s position related to regulatory and safety policy
+ Providing internal partners (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory and safety policy perspective on key issues
+ Monitoring, analyzing, and anticipating changes in the regulatory environment, including their impact to Amgen’s policy strategy
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
+ 8+ years’ experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience
+ Experience in building relationships with key stakeholders (e.g., trade associations, bio-pharmaceutical companies, FDA, EMA, other national competent authorities)
+ Validated strategic and analytical abilities
+ Knowledge of regulatory, R&D, safety, and drug development issues
+ Experience in policy development
+ Strong presentation and interpersonal skills
+ Comprehensive knowledge of the bio-pharmaceutical 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 creative 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 demonstrates 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._**