Senior Clinical Trial Regulatory Advisor - Previous experience working with submissions in multiple countries - Argentina at Syneos Health in ARG-Buenos Aires-Hybrid

Job description

Senior Clinical Trial Regulatory Advisor - Previous experience working with submissions in multiple countries - Argentina Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Responsible and accountable for the customer-focused leadership and management of CTRA deliverables within a country, region or globally, within the assigned projects or programs during start-up, site activation and throughout the study life cycle. Contributes to the technical and operational aspects of the CTRA deliverables of the assigned projects. Compiles core packages, completes project regulatory assessments, submission forms and uploads documents to CTIS (Clinical Trial Information System) as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), Site Activation Management and Project Sponsor. Responsibilities: Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway. Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments. Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs. Work with the project leadership to define the strategy to execute against milestones and key deliverables. Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team. Assumes accountability on the CTRA operations on specific project activities which may include but not limited to: Perform a Project Regulatory Assessment in agreement with the client. Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables. Prepares/assists and presents overall submission strategy and status at client meetings and communicates outcomes to project team. Review clinical trial study core documents (such as labelling for regulatory compliance etc.) Coordinate and/or perform regulatory core submission (including fo