Jonathan Donaldson Email & Phone Number

Cambridge, Ma, Us

Boston, Massachusetts, United States

Modern Regulatory Affairs organizations are enabled by capabilities made up of a combination of process, data, and technology. Data is the future within Regulatory, and Registration Tracking is at the core of achieving it. This information is in demand to support product release, demand management and the funding of market opportunities in an HA data driven environment (xEVMPD, IDMP, EU FMD, UDI, eCTD 4.0 and more) and sets the launching pad for data versus document driven world. This role requires me to keep Sanofi current, innovative and compliant with the constant changing Health Authority requirements in order to facilitate the approval of Sanofi products and their lifecycle management submissions. The function I support enables the approval and compliance maintenance of Sanofi’s products in 163 countries requiring 50,000+ submissions per year.In this role, I perform as a strong analyst who can combine consulting, process excellence, information modeling, modern Information Technology expertise with pharmaceutical and biotechnology regulatory knowledge to drive the ongoing transformation and continuous improvement for the capability.I serve as a driver for the ongoing innovation of initiatives intended to support the maintenance of compliant operations and the modernization of workflows. My role partners with external groups to influence future process, standards and technology evolutions. In addition to ensuring continuous improvement advances, I am responsible for building internal and external partnerships for standards and technology evolution. Finally, I am responsible for the identification, delivery and evolution of projects within this Capability. I am expected to possess a clear understanding of integrated, platform technology and work closely with process owners, stakeholders, ITS and external service providers to drive the evolution of the capability.

Cambridge, Massachusetts, United States

In this role, I worked with an interdisciplinary team to help develop the strategy for Sanofi to implement Veeva Vault RIM Registration Tracking (RT) as a new all-in-one RIM solution which would be the capstone on Sanofi’s “Horizons” program. This was a watershed implementation and migration for Sanofi—impacting 16M object records, 3.5K products, 10K users, and 3 new integrations—all impacting 14 Sanofi functions/regions. In addition to supporting the solution confirmation for all applicable regulatory processes, the most significant aspect of the RT Project is the migration of the Sanofi SHARE (Liquent Insight) application to Vault RIM, which began in Q4 2019 and will conclude in Q3 2020. Serving as Principle Capability Manager within the BPO&E organization, reporting to the transverse Head, my primary function is to leverage Vault expertise against high-level mastery of all Regulatory activities within Vault scope to ensure that there are no critical gaps between the functionality and what the tool must cover. While technical in nature, this is primarily a communications-focused role, with a synaptic purpose; I am able to best serve the organization by knowing enough of what is happening in a multiple of places by adding consistency to the methodology and approach in which diverse functional groups understand our tools and processes.

Cambridge, Ma

In this role, I served primarily as the system owner of Genzyme’s Regulatory Information Management system (IRiS), overseeing system development, governance, and maintenance. This gave me insight into all aspects of software lifecycle management—made even more interesting by the growing complexity of the RIM landscape. After being acquired by Sanofi Corporation, Genzyme was initially able to continue operating as an independent entity. However, eventually we integrated, which included not only our sizable organizations, but also our ways of working, systems and tools. In supporting this transition, I supported the migration/convergence of Genzyme data into various Sanofi systems (and the eventual decommissioning of these tools). This allowed me to serve as a change-agent for the newly coined Sanofi-Genzyme business entity, and to guide and inspire my colleagues in Cambridge, MA towards a new future with Sanofi.

Cambridge, Massachusetts, United States

In this role I grew with Genzyme as we expanded from a small to mid-sized biotech company with the acquisition of products from companies such as BCI, AnorMED, and SangStat. This was an era of great expansion for us as within a just a few years we went from our first BLA approval in the US to suddenly registering an ever-expanding portfolio of rare disease products in all corners of the world. I learned a tremendous amount about the complexity, opportunities, and pitfalls of becoming truly global against the backdrop of the digital revolution and the exciting advent of RIM.

Cambridge, Massachusetts, United States

In this role I supported the international Regulatory Affairs Department with the administrative aspects of global registration maintenance; including legalizations, procurement of export certificates, and the planning and execution of quarterly global meetings.

Master Of Science (M.S.), Regulatory Affairs And Drug Policy

English, Writing