The Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence (RPI), utilizes knowledge of the scientific, regulatory, and business environment regarding how medicinal products and medical devices are developed, evaluated, authorized and monitored once marketed to support and guide product development strategy.  Develops and maintains strong partnerships with regional area and affiliate staff that interact with Health Authorities (HAs). Monitors external environment for evolving policies that impact product development, lifecycle maintenance and on-market support working closely with Subject Matter Experts (SMEs) to analyze impact. Establishes, develops, and maintains relations with HAs and peer companies, industry trade associations, and external organizations regarding scientific and regulatory policies.  Leads cross-functional, multidisciplinary teams, to comment to HAs. Through knowledge gained, assists company to comply with scientific, ethical, statutory, quality, and business requirements. Works independently, requires minimal supervision, assumes project responsibility, and interacts with senior management.

• Independently manages and leads U.S. regulatory policy and intelligence activities, defining scientific and regulatory policy initiatives that advance company priorities.
• Serves as the subject matter expert for CMC, product quality, pharmaceutical quality systems, and supply chain management policy; analyzes proposed regulations and distributes impact assessments to key internal stakeholders and senior management within various functional areas.
• Contributes to the regulatory product strategy that is developed by the Global Regulatory Leads and Regulatory leadership.
• Establishes and cultivates strategic relationships with internal and external partners; identifies and acts on opportunities to strengthen AbbVie's standing through active participation in policy-related forums and industry networks.
• Research, authors, and presents briefings, policy positions, and high-level communications to senior management with clarity and strategic focus.
• Identifies through partnerships and internal subject matter experts, regulatory policy priorities for assigned topics or therapeutic area(s) and coordinates communication of final policy intelligence to support the implementation of new regulatory policy and guidance across AbbVie functions​.
• Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies​.
• Manages AbbVie's regulatory policy commenting process, applying knowledge of FDA precedents and procedures to produce influential submissions that advance AbbVie's policy positions.​
• Actively engages to shape the US & ICH scientific and regulatory policy in the regulatory CMC, product quality and supply chain management space, partnering with cross-functional experts, and leading regulatory advocacy through trade associations, external organizations, and guidance consultations.
• Identifies US and scientific policy trends in the CMC, product quality and supply chain management space that could impact development programs, compliance, and assurance of product supply to patients