Director Public Policy - Science and Food and Drug Administration Policy

Regeneron Pharmaceuticals · United States

Build Our Future Together The Director of Policy & Government Affairs – Science and Food and Drug Administration (FDA) Policy will lead Regeneron’s science and FDA policy portfolio, developing, shaping and influencing government and multinational organization policy related to the scientific research and development of biopharmaceutical medicine and cell and gene therapy across the product lifecycle. Relevant issues include but are not limited to product approval standards and pathways, scientific ethics and integrity, clinical trial activity, evidence development, manufacturing and CMC criteria, and biosimilars. Although US-focused, the position may also support the ex-US Public Policy & Government Affairs lead on key science and biotechnology medicine policy around the world as needed. When & where:

• Work Location: Washington, D.C.
• Hybrid: 4 days per week on site

• Engage with internal subject matter experts and leaders to understand Regeneron’s business and corporate interests, recognize policy risks and opportunities, and determine short and long-term policy objectives in order to navigate and balance competing interests and objectives
• Communicate Regeneron's policy positions and initiatives to internal and external audiences through various channels;
• In collaboration with relevant internal team members, organize and participate in events, conferences, and forums to promote Regeneron's policy agenda;
• As needed, represent the Regeneron PP&GA team at key stakeholder meetings and engage with key external partners at meetings to identify opportunities for collaboration to advance common policy priorities.
• Engage with industry associations, advocacy groups, and other external stakeholders in collaboration with the alliance development lead to build coalitions and advance shared policy objectives
• Develop and advance strategic public policy positions and initiatives that align with and advance Regeneron's business objectives;
• Monitor and analyze legislative and regulatory developments at the federal, state, local, and international levels to determine the potential impact on and importance to Regeneron;

• Bachelor’s degree is required; advanced degree/s in Public Policy, Political Science, Law, or related field and science background strongly preferred.
• Minimum of 12 years of relevant experience in science and regulatory policy, preferably with substantial experience at the US FDA
• Proven record of successfully crafting and influencing public policy and navigating complex and highly technical issues
• Strong understanding of the biopharmaceutical industry, including regulatory and legislative processes
• Develop and execute strategic advocacy plans, including proactively crafting and vetting legislative and regulatory proposals to advance company priorities and mitigate risks;
• Provide expert advice and guidance on policy and regulatory matters to internal stakeholders