Senior Clinical Trial Regulatory Advisor - Previous experience working with submissions in multiple countries - Argentina

7257 Syneos Health Argentina S.A.; Buenos Aires; Híbrido; ARS 139.018.000 - 200.803.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Senior Clinical Trial Regulatory Advisor in Argentina to lead regulatory activities for submissions across countries. You will prepare core packages, manage CTIS submissions, and report on regulatory status to project teams and clients.

The role requires strong GxP knowledge, excellent communication, and the ability to manage complex timelines and risk assessments. This is a global opportunity to influence regulatory strategy within a leading life sciences partner,

Formación

• Bachelor’s degree or higher with strong regulatory knowledge and drug development experience.
• Experience with GxPs (e.g., GCP, ISO14155) and regulatory submissions.
• Excellent communication, presentation and stakeholder management skills.

Responsabilidades

• Lead regulatory deliverables for country, region or global scope.
• Prepare submission strategies and manage CTIS documents.
• Coordinate regulatory assessments and liaise with sponsors and teams.
• Develop client relationships and provide regulatory guidance.

Conocimientos

Regulatory expertise

Project management

Regulatory writing

Educación

Bachelor’s Degree

Higher Degree Preferred

Descripción del empleo

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.

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 for example EU Clinical Trial Regulation PartI 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 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. 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/Project teams. Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects. Oversees collation, quality review, and submission of country-specific applications. Identify gaps in the evidence base supporting submissions and contribute to the development of regulatory recommendations and decisions. Reviews the project budget against project milestones and budget to ensure project profitability. Uses professionally recognized tools for planning and management of scope and ensures effective budget management. If out-of-scope work is requested, notifies the Site Activation Management, and tracks out-of-scope work until it is assigned to back log. Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues. Explain complex technical regulatory issues into plain language to nontechnical audiences. Facilitates processes and communications within the CTRA Team. May contribute to development of new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in development activities including strategic account/ portfolio client meeting and/or reviews of proposals. Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate Syneos Health departmental teams. Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. Use communication skills to transfer knowledge to entry-level employees. Apply technical expertise in multi-disciplinary teams and explain the importance of adapting to the changing regulatory environment. Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Qualifications

Bachelor’s Degree, Higher Degree Preferred. Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. Experience in working to applicable GxPs (e.g., GVP, GCP (Good Clinical Practice), ISO14155) etc. Subject matter expertise in current regulation frameworks (e.g., regulations and guidelines specific for non- interventional studies, clinical trial, and medical device regulations). Strong knowledge of clinical research management processes. Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken) Team-oriented approach. Strong negotiating and problem-solving skills. Demonstrate an ability to provide quality feedback and guidance to peers. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Discover what our 29,000 employees already know

Work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Learn more

Learn more about Syneos Health. http://www.syneoshealth.com