Senior Regulatory Science and Strategy Lead - EMEA Real World Solutions

<p>Overview</p><p>Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions.  We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in development and growth.</p><p></p><p>Role<br/>As a Regulatory Science and Strategy Senior Principal within IQVIA’s EMEA RWS business, you will take on a variety of roles that focus primarily within the following core areas:</p><ul><li><p>client/project leadership,</p></li><li><p>maintaining and further developing expertise on the regulatory landscape (focusing on real world evidence and the European Medicines Agency in particular),</p></li><li><p>business development,</p></li><li><p>firm/operational leadership roles</p></li></ul><p></p><p>The role has two areas of focus.</p><p><br/>Firstly, a senior principal is expected to deliver outstanding client service, while building trusted relationships with new and existing clients while enhancing our global network of regulatory science and strategy capabilities to support life science clients to use Real World Evidence more widely and effectively for regulatory purposes.  </p><p></p><p>Secondly, the role encompasses acting as a subject matter expert and thought leader for Regulatory Affairs in Europe (western and eastern). It covers regulatory affairs for all phases from drug development:  pre-clin, clinical, submission/approval/launch, and post-launch development and commercialization activities.</p><p></p><p>An in-depth knowledge of the entire drug development process from EMEA health authority requirements perspective e.g., European Medicine Agency (EMA) and local national competent authority is essential to success. This subject matter expert role interacts with those experienced in regulatory affairs, clinical development and real-world insights for post authorization studies. As a member of the MEP team, they participate in the development of proposal strategy and regulatory pathway including for PASS.</p><p></p><p>The role interacts with regulatory and drug development leaders around IQVIA relative to customers who require regulatory expertise. The role also interacts with Marketing and Sales/BD across IQVIA as they generate customer requests.</p><p>Finally, this role is part of the senior/strategic face of IQVIA to customers for IQVIA EMEA regulatory affairs services connected to Post Authorisation Safety Studies(PASS), Drug Utilisation Studies and external comparators studies . Since the European pharma market is one of the largest in the world, this requires considerable breadth of knowledge and experience.</p><p></p><p>Responsibilities</p><ul><li><p>Support IQVIA Real World Solutions teams to sell and deliver customer programs of Real World Evidence generation for regulatory audiences (notably Post Authorisation Safety Studies, Drug Utilisation Studies and External Comparator Studies)</p></li><li><p>Lead European regulatory intelligence activities. Ensure a robust process to monitor the external regulatory environment and to identify and communicate new or emerging information that is relevant to IQVIA innovative offerings and to our clients’ needs.</p></li><li><p>Remain current on emerging regulatory frameworks, pivotal regulatory decisions, and industry trends in order to anticipate and identify new business challenges and issues with assigned clients.</p></li><li><p>Shape and influence regulatory strategy to benefit company, based on emerging regulatory frameworks, scientific innovation, and IQVIA’s Real World Solutions portfolio</p></li><li><p>Create and elevate new business opportunities through the identification of value-added follow-on work and identify new revenue opportunities with existing and new client organizations.</p></li><li><p>Act as principal owner of regulatory science element of client engagements; ultimate responsibility for client satisfaction and delivering high levels of quality/added value: Specifically:</p></li></ul><p></p><ul><li><p>Advisor on the strategy to deliver EMEA regulatory services to customers concerning PASS, DUS and external comparators.  The role requires deep understanding of customer needs and develops appropriate strategy and delivery plans for services. Key services include regulatory consulting and fulfilling EMEA requirements for life cycle management especially regarding Post authorisation Safety Studies.</p></li><li><p>Deep knowledge of the activities, outputs and ongoing workstreams of the PRAC, CHMp, EMA and EnCEPP are essential</p></li><li><p>Capability to work collaboratively across IQVIA when customer requirements involve regulatory affairs services</p></li></ul><p></p><ul><li><p>Customer experience developing, delivering, and selling regulatory services to biotech, small-, mid-, and large Pharma.</p></li><li><p>Provide follow-up with clie