Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Home Based

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Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Home Based 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 - Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway. - Participates in strategic development activities including account/ portfolio client meetings. - May participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. - Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs. - 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 - Update s 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 for example EU Clinical Trial Regulation Part I dossier). Perform study level tracking of the submission packages. - Centralize and perform a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as Requests for Information RFIs (Requests for Information) during the submission review). - When required, employ effective technical and regulatory writing skills to author regulatory documents for submissions purpose upon Sponsor agreement. - Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects. - Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Pro

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