.We are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains.About You - experience, education, skills, and accomplishments:Bachelor's or master's degree in pharmaceutical sciencesAt least 5 years of relevant work experience in regulatory affairs or in supporting regulatory professional services/ Consulting projectsRelevant experience in clinical trial data optimization, clinical data management, MAA submissionsRegulatory Intelligence - Pharmacovigilance, Clinical Trial, New and post approval registrationsCustomer facing or customer service experience desirableDemonstrated ability to learn on new domains, understand internal systems & processes and perform at the same timeIt would be great if you also had:Exposure to regulatory consultingMaster's degree in regulatory affairsA flexible and collaborative approach to workAbility to prioritize effectively and adopt a systematic approach to tasksWhat will you be doing in this role?Project Delivery Support (70%):Become an integral member of the delivery team within the Life Sciences Consulting group.Act as a point of contact for the customer throughout a project's lifecycle.Act as the project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.Escalate any project risks and delivery issues to the Manager, Regulatory Services for action and resolution.Support and deliver small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.Deliver on routine projects, new development and one-off requests.Business Development (30%):Support to any received Requests for Information (RFIs) and Requests for Proposals (RFPs).Work with professional services colleagues to provide robust effort estimates for scoped projects.Support the creation of customer facing materials to support commercial discussions such as samples.The role will sometimes require you to work individually or as part of a team with knowledge sharing or as a team player.Projects you will be working on:Various regulatory consulting projects such as data monitoring, content authoring, regulatory landscape, precedence analysis, newsletters, custom dashboards, guidance interpretation, gap analysis. The team works for global clients in multiple domains of clinical and drug regulatory space for multiple product types.About the Team:The team consists of six colleagues based in Barcelona and reporting to the Manager of Regulatory Solutions, as well as other colleagues in the US, India, and Europe. The Clinical and Regulatory Consulting Team works towards adding value to data from different sources and providing professional regulatory services to our global clients
