Alexis Reisin Miller

Provide strategic counsel to senior R&D, Regulatory, Policy, and enterprise executives on how global regulatory and political environments shape development priorities and market access. Lead the Global Regulatory Policy organization, shaping policy positions and external engagement strategies across U.S., EU, Asia-Pacific, and LATAM. Drive coordinated global advocacy to support patient-focused innovation through modern, sustainable regulatory frameworks. Align cross-functional partners across Regulatory, R&D, Commercial, and Public Policy to deliver enterprise-wide policy goals. Represent Merck in senior leadership roles across PhRMA, BIO, IFPMA, DIA, and multi-company coalitions, influencing regulatory modernization and international convergence.

Led U.S. regulatory policy strategy supporting enterprise, development, and portfolio priorities across therapeutic areas. Advised senior global leadership on the business impact of emerging regulatory and legislative trends, influencing development strategy and external engagement. Directed U.S. policy intelligence support, impact analysis, and coordinated advocacy across regulatory, legislative, and administrative environments. Shaped company positions on expedited pathways, evidence and labeling strategy, digital/AI‑enabled regulatory approaches, and regulatory modernization. Represented Merck in senior U.S. external roles across PhRMA, BIO, and DIA, including design and leadership of DIAmond and executive‑level sessions with FDA and global regulators.

One of two U.S. leaders for Regulatory Science & Policy, shaping strategic engagement with FDA and cross-agency partners for priority development programs. Led policy development across PFDD, Benefit–Risk, CGT, Pediatrics, and Rare Disease, and advanced frameworks for digital therapeutics and cloud-based submissions. Principal policy lead for PDUFA VII proposals; contributed to implementation of PDUFA VI and broader modernization priorities. Served in leadership roles across BIO committees, advising senior executives across BIO, PhRMA, and ARM on policy risks, opportunities, and enterprise implications.

Helped establish and lead Eisai’s Regulatory Policy function, supporting development, evidence, and commercialization strategies across therapeutic areas. Directed U.S. regulatory policy, intelligence, and formal commenting; briefed senior regulatory and development leaders on emerging scientific, policy, and legislative shifts. Provided regulatory/legal counsel across PFDD, RWE, biomarkers, pediatrics, CMC/Quality, advertising & promotion, and expanded access, ensuring alignment with global evidence and labeling strategies. Partnered with global Regulatory and R&D leadership to align policy positions across labeling, evidence expectations, postmarketing commitments, and FDA engagement. Served as CMC/Manufacturing regulatory counsel supporting the Legal team, and negotiated clinical trial agreements and related development and manufacturing contracts.

Partner in a leading FDA regulatory practice advising biopharmaceutical, consumer product, technology, dietary supplement, and cosmetic clients on complex regulatory, policy, and enforcement matters. Led strategic counseling on development, labeling, promotion, manufacturing quality, transparency, and multi‑agency compliance (FDA, FTC, CPSC, OIG), integrating legal, scientific, and commercial considerations. Directed regulatory due diligence for M&A transactions and negotiated regulatory provisions in manufacturing, quality, licensing, and commercial agreements to support enterprise risk management and deal strategy. Provided high‑value counsel to executive and cross‑functional teams on regulatory positioning, lifecycle strategy, and the business impact of emerging policy and enforcement trends.

Served as Regulatory Counsel in CDER’s Office of Regulatory Policy, drafting and interpreting FDA regulations and guidances to support consistent, science‑based regulatory decision‑making across review divisions and product modalities. Developed regulatory policy responses to citizen petitions and addressed cross‑center policy issues with implications for development, approval, and post‑market requirements. Collaborated closely with the Office of Chief Counsel on legislative, regulatory, and litigation matters, ensuring alignment of legal interpretation, scientific considerations, and public health priorities. Contributed to governance, risk analysis, and cross‑functional policy formulation during a period of evolving regulatory expectations and heightened public scrutiny.

Advised clients across drugs, biologics, devices, OTC, foods, and cosmetics on development, labeling, promotion, compliance, and regulatory strategy. Supported regulatory due diligence, commercial agreements, manufacturing and quality provisions, and submissions related to FDA‑regulated products. Conducted legal and regulatory analysis for matters involving FDA, FTC, and CPSC; counseled clients on enforcement risk, product claims, advertising and promotion, and lifecycle regulatory obligations. Collaborated with scientific, clinical, and commercial teams to align regulatory strategy with business objectives and evolving legislative and policy requirements.

Advised clients on FDA and cross‑agency requirements for foods, dietary supplements, and food‑contact materials, including preparation of Food Contact Notifications, GRAS submissions, and Drug Master Files. Provided regulatory guidance on safety, manufacturing, and compliance issues; supported clients navigating complex technical and statutory requirements for packaging and food‑related products. Engaged with toxicologists, scientists, and quality teams to align regulatory filings with evidentiary expectations and agency standards.

Served as in‑house regulatory and legal advisor within a venture‑backed CRO model, supporting development‑stage clients across clinical, regulatory, and strategic needs. Negotiated clinical trial agreements and development‑related contracts; advised on regulatory pathway considerations, early evidence strategy, and compliance. Provided cross‑functional support to scientific, clinical, operational, and business development teams to align development plans with FDA expectations and commercial objectives.

Supported complex national pharmaceutical and blood‑product litigation, contributing to motions practice, depositions, fact development, and regulatory‑focused legal analysis. Conducted extensive document review and scientific/technical issue assessment to inform litigation strategy and case positioning. Analyzed FDA regulations, compliance issues, and product‑specific safety considerations relevant to multi‑district and multi‑party litigation.