Clinical Trial Regulatory Advisor - The position is to work with submissions in Canada - Argentina Home Based

Syneos Health; Argentina; Remote; ARS 139,474,000 - 201,463,000; Full time

Job summary

Syneos Health, Inc. seeks a Clinical Trial Regulatory Advisor to manage regulatory submissions for Canadian trials from a home-based position in Argentina. The role emphasizes compliance with GxP standards and cross‑functional collaboration on global teams.

You will review core documents, contribute to submission strategy, and ensure timely, high-quality deliverables across the study lifecycle. Strong English, communication, and teamwork are essential in this international, remote setup.

Qualifications

• Minimum of a BA or BS preferred.
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc.
• Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken English).
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary.

Responsibilities

• Provide regulatory and technical support for assigned regulatory work, review and finalise essential core documents, and manage submissions.
• Perform CTRA operations deliveries on specific project activities including regulatory leading functions to satisfy client requirements.
• Review study core documents (e.g., labeling for regulatory compliance) and prepare technical components of regulatory submissions.
• Contribute to agency interactions and support activities across the project lifecycle.
• Manage day-to-day regulatory activities for assigned projects within timelines, scope, budgets, and strategies.
• Serve as SME and assist team with day-to-day troubleshooting and problem-solving.

Skills

Regulatory knowledge

English proficiency

Stakeholder communication

Team collaboration

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Clinical Trial Regulatory Advisor - The position is to work with submissions in Canada - Argentina 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

Provides regulatory and technical support for assigned Regulatory work: review and finalization of essential core documents required for site initiation regulatory and core submissions performance (if applicable) from site startup until study end related submissions. Accountable core regulatory activities; including the agreed regulatory submission strategy and ensures tasks are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.

Responsibilities

• Perform the CTRA operations deliveries on specific project activities which may include in particular regulatory leading function which result in client satisfaction.
• Review clinical trial study core documents (such as labelling for regulatory compliance etc.)
• Contribute to and prepare the technical components of a regulatory core submission (such as EU Clinical Trial Regulation Part I and/or II) Contribute to or support with any agency interactions.
• Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Identifies and reports on areas of process and risk.
• 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.
• Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

Qualifications

• Minimum of a BA or BS preferred
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc
• Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken English) as well as a team-oriented approach.
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary.

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 lang