Consultant - Regulatory Solutions

Company: Clarivate
Company: Clarivate
Location: Spain - Barcelona
Commitment: Full time
Posted on: 2023-11-05 05:18
We are looking for a Consultant, Regulatory Solutions to join our team in Barcelona. The primary purpose of the Regulatory Solutions Consultant role is to support the proposal and delivery of regulatory consulting services globally. This includes working closely with the Regulatory Consulting Manager and other team members to ensure that all regulatory projects are delivered on time, within cost and at the highest quality.This is not a core submission profile, this is a great opportunity to lead several different projects which includes: Regulatory Intelligence & Regulatory Strategy, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, and pharmacovigilance projects. We work with companies with portfolios that include both chemical and biologics, as well as Medical Devices. With this role you will support global clients on their challenges when operating globally, providing regulatory intelligence support and helping them to be more efficient and strategic.The role will sometimes require you to work individually or as part of a team with knowledge sharing or as team player.About You – experience, education, skills, and accomplishmentsMinimum of a Bachelor’s degree in life sciences or Master’s degree in life sciences5-6 years’ experience in pharmaceutical regulatory affairs / regulatory intelligenceKnowledge of pharmaceutical and medical device regulatory affairs / regulatory intelligence across a given geographic area (e.g. Europe or North America) mandatory (familiar with drug pipeline, development / approval / marketing, regulatory concepts).Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, security standardsExpert knowledge of relevant marketsExcellent customer service skillsIt would be great if you also had . . .Experience in supporting regulatory professional services or projects desirable.Customer facing or customer service experience desirable.Strong problem management, troubleshooting and analytical skillsDemonstrated ability to work with and manage virtual teams to successfully deliver projectsDemonstrated ability to learn and understand internal systems and processesAble to work well under pressure in a demanding environmentIndependent worker with excellent time management and escalation skillsWhat will you be doing in this role?Responsibilities as follow:Project Delivery Support (80%)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 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 Regulatory Consulting EMEA Manager for action and resolution.Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.Support the delivery of non-regulatory professional services as required and agreed with both their direct and matrix managers.Deliver on routine projects and single requests.Business development (20%)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.About the teamYou’ll be reporting to the Manager, Research Analysis based in Barcelona.You’ll be part of a global team working on international projects.The team culture is dynamic, creative, and supportive – excellence, integrity, and care are in our DNA.You’ll have 40 annual paid hours of volunteering time and the chance of being part of an active volunteering community which promotes diversity and inclusion across the business.Hours of WorkWe offer a permanent position, 40 hours per week in Barcelona, EU hours. Hybrid, going to our central office 2-3 times per week.At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
View Original Job Posting