- Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and regulatory intelligence professionals, ensuring they are appropriately qualified, trained, and capable of providing necessary regulatory and policy leadership to support the GRAAS function and broader business
- Interpret and anticipate changes in the regulatory environment
- Communicate regulatory developments to stakeholders within Amgen
- Partner with Global Government Affairs, Global Value & Access, Global Development, Medical Affairs, Quality, Clinical Development, and others to align Global Regulatory and R&D policy priorities
- Lead key policy initiatives to shape the regulatory environment
- Lead the development of position/white papers to support key Amgen policy initiatives.
- Monitor legislative, regulatory and guidance developments and coordinate Amgen review and comment on documents.
- Oversee the GRAAS Expert Review Group responsible for Amgen responses to published regulatory documents
- Ensure Global Regulatory and R&D policy awareness and participation on key committees, conferences, and trade associations
- Lead global policy initiatives or support regional activities for global policy initiatives
- Keep abreast of Amgen product development plans and issues WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications
- Doctorate degree & 8 years of regulatory affairs experience OR
- Masters degree & 10 years of regulatory affairs experience OR
- Bachelors degree & 12 years of regulatory affairs experience AND
- 8 years of direct managerial experience. Previous experience managing other managers Preferred Qualifications
- Advanced scientific, legal or public health degree (i.e. PhD, PharmD, MBA, JD) or bachelors with at least 15 years of pharmaceutical industry-related experience in drug development, public health and/or regulatory policy or law.
- Trade association or coalition involvement and anticipates changes in the external environment to develops action plans
- Experience developing and implementing advocacy strategies designed to spur external actions
- Recognized expertise as an external thought leader
- Ability to establish strategic relationships with internal and external customers and partners; interact with regulators, customers, or other outside stakeholders on business issues
- Demonstrated strong written, spoken and presentation communication with ability to research, write briefings, policy positions and high-level communications
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Demonstrated leadership skills and effectiveness in the areas of influence, team leadership, articulating and taking a position, negotiation, and conflict resolution.
- Effective team building capabilities and demonstrated effective teamwork and people management skills with ability to adapt to diverse interpersonal styles
- Demonstrated ability to make quality decisions in the absence of complete data and with substantial uncertainty. They will also embody the Amgen leadership attributes which are:
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver resultsThriveWhat 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 annual base salary range for this opportunity in the U.S. is $277,673 - $339,378. In addition to the base salary, 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 possible Amgens Commitment to Our Staff At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our people-first philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. 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.
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Head of Regulatory Affairs Policy - Thousand Oaks, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Head of Regulatory Affairs Policy & Intelligence
Live
What you will do
Lets do this. Lets change the world. In this vital role as Head of Regulatory Affairs Policy & Intelligence you are responsible for shaping Amgens regulatory policy strategy and leading the global policy and regulatory intelligence teams.
Reporting to the Senior Vice President, Global Regulatory Affairs, this key senior leadership role serves as a recognized regulatory policy leader and influential spokesperson in support of Amgens global regulatory initiatives.
The Head of Regulatory Affairs Policy & Intelligence leads a team of remote professionals located in both the United States and Europe who are responsible for harnessing their diverse, broad, and industry-leading expertise to influence regulators on important issues in drug development and regulation that benefit Amgens business and the patients we serve.
The evolving regulatory landscape and changes in the competitive market require agile and strategic regulatory policy engagement to support Amgen business needs. This leader will deliver leading-edge regulatory results by identifying policy barriers and emerging trends, developing advocacy plans built upon science-based positions, engaging broad stakeholder networks, and ultimately effecting change in regulatory policies that reduce regulatory risk and improve efficiency in drug development.
Responsibilities
