Regulatory Policy and Intelligence – US Directo…

Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Regulatory Policy and Intelligence - US Director Live What you will do Let’s do this. Let’s change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen’s goals and priorities. In this vital role you will lead the development and articulation of Amgens positions on regulatory policies that impact Amgens business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence. Key Responsibilities include: Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen’s product portfolio, including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud-based submissions) Engages US regulatory authorities, industry, and professional associations at the policy level Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgens position related to regulatory policy Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies Masters a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products. Leads the development and execution of strategic plans for each assigned policy area. Ensures that Amgens regulatory policy positions are successfully represented to inform policy development and implementation Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The regulatory policy and intelligence professional we seek has a deep knowledge and understanding of the U.S. regulatory environment and can provide insights to internal stakeholders, as well as shape the external regulatory environment to support Amgen priorities and has these qualifications Basic Qualifications: Doctorate degree and 4 years of related experience Or Master’s degree and 7 years of related experience Or Bachelor’s degree and 9 years of related experience Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.. Salary Range 188,796.00 USD - 222,457.00 USD Apply tot his job Apply To this Job