- Manages Amgens global regulatory policy commenting process and staff providing knowledge of FDA policy precedents and process to deliver influential commenting deliverables to advance Amgens policy positions
- 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 Amgen's 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 and R&D policy topics as assigned. Leads the development and execution of strategic plans for each assigned policy area.
- Ensures that Amgen's regulatory and R&D 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
- Ensures direct and dotted line staff are compliant with required training and SOPs, and conducts annual review of staff training records for direct line reportsWinWhat 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 experienceOr Masters degree and 7 years of related experienceOr Bachelors degree and 9 years of related experience ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.
Global Regulatory Policy and Intelligence Director - Washington D.C., United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Global Regulatory Policy and Intelligence DirectorLive
What you will do
Lets do this. Lets change the world. Global Regulatory and R&D Policy 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 Amgens goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as Amgens U.S. Lead for Regulatory Policy and Intelligence.Key Responsibilities include: