We are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, regulatory strategy and QA services, among others, and we would love to speak with you if you have any of the skills or expertise in the quality & regulatory affairs and consulting domain.
About You – experience, education, skills, and accomplishments Bachelor's or master's degree in pharmaceutical sciencesAt least 5 years of relevant work experience in quality affairs & regulatory affairs or in supporting quality & regulatory professional services/ Consulting projects.It would be great if you also had :Exposure to regulatory consulting
Master's degree in regulatory & quality affairs
Customer-facing or customer-service experience
What 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 the successful delivery of each assigned project; which includes coordination and tracking.Escalate any project risks and delivery issues to the Manager, of 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 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 sharingProjects you will be working on Quality Management System (QMS): set-up, maintenance, certification readinessImpact/Gap assessment: review and implementation of changes related to new/updated legislation and standardsProcess and organizational change management: workshop, SOP and workflow orientedAudits: Performing and receiving audits from Certification Bodies in GxP and ISO QMS regulated systemsInspections: Performing and receiving inspections from Competent Authorities (back-room and front-room)Project management: set-up and implementation of projects related primarily to RA, QA, Clinical affairs and Vigilance as well as implementation of related Enabling Technologies (platforms)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. The team works with internal databases like Cortellis intelligence, etc., and with external local consultants/ partners. The team here demonstrates good networking skills and establishes rapport with the client and internal/external stakeholders.
Hours of Work This is a permanent full-time position at 40 hours a week (35 hours during July and August).
The working schedule is flexible, mostly centered on CET time zone with the occasional need to accommodate late or early meetings with US or East Asia time zones.
The position is hybrid going to the office in Barcelona 2-3 times per week.
What We Can Offer You / Company Benefits A modern culture environment combined with all the financial and stability advantages of working for a large business.Active volunteering community, with 40 annual paid hours of volunteering time.Private Health and Life & Disability insurances.Tax-free benefits (Ticket Restaurant scheme, kindergarten and transport cards).Language classes (Catalan, Spanish and English).Global and dynamic employee base (more than 20 nationalities).30 working days of vacation.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.
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