Robert Rainer Email and Phone Number

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

Leadership of Regulatory Affairs Information Management (RIM) with a portfolio of projects consisting of over $30MM in annual budget. Worked closely with business units to identify and execute RIM strategic initiatives in alignment with the overall business strategy, both short and long-term. Developed the overall business and technology strategy enabling Regulatory Affairs to meet its short and long-term objectives. Member of the Regulatory Affairs Senior Leadership Team and the R&D IT Senior Leadership Team working with all levels of the organization, largely SVPs and VPs to define Regulatory Affairs and Information Management strategy in partnership with R&D IT. • Completely built the eCTD submissions capability from the ground up. This included staffing, process development, eCTD tool assessment, validation and implementation, and educating all R&D functions on the internal value of the eCTD standard as well as other industry standards (SDTM, ADaM, Define.xml, ODM). Was the first J&J Company to implement eCTD capabilities• Led the development, validation, implementation, and ongoing support for several large RIM system capabilities including global submissions planning, product registrations, health authority commitments tracking, health authority correspondence management, content management, electronic submissions archive, submission logging, dossier content planning, and template implementation.

Technical Project Leader for U.S. Human Health Information Services. Was responsible for all aspects of strategic technology planning and execution for U.S. Human Health. Was responsible for the integration of several complex global clinical and regulatory systems including CTMS, CTS, and Content Management.