Greater Philadelphia
An innovative Regulatory Affairs Operations / Regulatory Information Management (RIM) Leader with over 22 years of experience including extensive global experience in large Fortune 35 organizations as well as fast paced, high growth, small and medium sized pharmaceutical and biotechnology companies. A driver of change in culture, behavior, and technology through innovative approaches and a results-oriented industry leader pioneering and managing organizational transformations to best-in-class industry technologies and optimized business processes. A passionate and energetic business partner that employs a unique consultative approach and inspiring teams to deliver under extraordinarily aggressive timelines and highly complex operational challenges. Work closely with all R&D functions and key stakeholders throughout the enterprise to ensure compliant and timely regulatory filings while providing guidance on regional and country specific dossier requirements and filing strategies.
Hired to prepare the R&D organization for their first NDA filing in the U.S. with subsequent filings in China, Japan, South Korea, and the EU. Quickly mobilized a small team to assess a short list of vendors to partner with for transitioning the organization from a completely outsourced submission publishing model to a hybrid model while also moving parts of the process to a well-established Indian firm to leverage more cost-effective offshore resources. This resulted in a 75% reduction in submission publishing costs, while gaining full end-to-end RIM capabilities and in-house competency to manage our own regulatory applications. • Implemented an end-to-end RIM system in support of our product pipeline and the filing of Trevena’s first marketing application. The suite of tools included product registration, submission planning, content planning, document management, submission publishing, report level publishing, submission tracking, correspondence management, commitment tracking, FDA electronic secure gateway, electronic signatures, submission archive, and collaborative authoring. • Successfully led the cross-functional submissions sub-team for the filing of an NDA for a novel NCE (oliceridine, a G protein-biased ligand binding to the mu opioid receptor). Responsible for the planning, managing, publishing, and continuous reporting of all source components and publishing milestones for the US NDA filing (505(b)(1)) along with the ongoing global filings in China, Japan, South Korea, and the EU.
Led large Regulatory Affairs Operations technology and process initiatives in the Pharmaceutical and Biotechnology space. Serves as both a subject matter expert and overall lead for the design and implementation of Regulatory Information Management (RIM) systems and related processes. • Led large business process and systems initiatives in core areas of focus for Regulatory Affairs Operations organizations including submission planning and tracking, table of contents development, eCTD and NeeS submission publishing, regulatory CMC change control, correspondence management, registrations tracking, labeling operations and company core data sheet processes, commitments tracking, aggregate and safety reporting, submission archival and retrieval, investigator management, and submissions content authoring across Clinical, Nonclinical, CMC, Regulatory, QA, and Safety. • Worked closely with large cross-functional teams and functionally aligned sub-teams with representatives from all key R&D and Commercial functions to develop process and supporting systems to streamline the entire development process from asset identification / acquisition through post-marketing life cycle management of key assets.
Led the IT integration / transformation global project portfolio in a highly matrixed cross organizational structure across eight operating companies. Responsible for a portfolio of ~50 projects and over $70MM budget globally. • Developed and implemented the global portfolio governance model and serve as the lead for ongoing governance activities. • Responsible for assessing emerging standards in the medical device space to enable the organization to move quickly to the eCopy electronic submission standard for medical device submissions and to develop a strategy to phase in electronic submissions. The eCopy standard was introduced as part of the IT portfolio for all 510(k)s and PMAs in early 2013 with a phased approach for IDEs and PDPs. Led the overall transition to the eCopy standard as a Project Manager for the 510(k)s submissions and ensured alignment with known information regarding MDR requirements.
Leadership of global Regulatory Affairs Operations. Accountable for all Regulatory Submissions filed globally with more than 10,400 annual submissions including major marketing applications (NDA/MAA), clinical trial applications (IND/CTA) expedited safety reports, labeling supplements, line extensions, briefing books, amendments, supplements, lifecycle management and maintenance submissions. Developed and maintained the overall Regulatory Affairs business strategy including technology roadmap development and operational plans aligned closely with the various R&D functions. • Completely built the Regulatory Operations and eCTD submissions capability from the ground up. This included staffing, process development, eCTD tool assessment, validation, and implementation. • Led a large cross-functional team chartered with the development, implementation, and governance of Data Standards across all of Endo including defining a cross-functional data stewardship and data / information architecture. • Introduced the concept of master data and a system to serve as a single source for critical data about drug products, manufacturers, manufacturing sites, health authorities, and key contacts and contact roles. • Responsible for a portfolio of products consisting of 9 globally branded assets including 6 (505(b)(1)) and 3 (505(b)(2)) applications in the U.S and over 20 applications globally including 7 EU Applications (3 Centralized Procedure, 2 Mutual Recognition Procedure, and 2 National Procedure) and 8 ROW applications including 3 NDS applications in Canada, 2 JNDA applications in Japan, and 3 MENA based applications in Jordan and Israel. • Accountable for a global portfolio of over 120 generic drugs and all associated submissions