30 oct
Syneos Health
Buenos Aires
OverviewPrincipal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Argentina, Mexico or Brazil.
Home Based.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.Join to apply for the Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Argentina,
Mexico or Brazil Home Based role at Syneos Health.Job ResponsibilitiesCollaborates 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.Line management responsibilities for staff members, including interviewing, hiring, coaching, performance management, and approvals related to salary, time, and leave.
Advises staff on policies and procedures.Develops and maintains strategic relationships with customers; proactively assesses client needs and ensures project deliverables meet internal and customer expectations.Defines project strategy with project leadership and presents regulatory strategy and status at client meetings; communicates outcomes to the project team.Manages regulatory activities for projects with complex profiles; ensures quality deliverables and controls risks and timelines.Regulatory submissions: coordinates core submissions (e.g., CTA/Dossier) and performs study-level tracking of submission packages.Performs regulatory writing as needed and prepares core clinical trial application dossiers for amendments/modifications during lifecycle maintenance; oversees documentation and submission quality.Reviews clinical trial core documents (e.g., labeling for regulatory compliance)
and maintains knowledge of applicable regulations and guidelines across pre- and post-market requirements.Maintains current knowledge of regulations and guidelines; identifies relevant laws and guidance for healthcare products.Supports management in reviews and presentations at project or departmental meetings; helps develop training for departmental teams.Ensures adherence to quality standards and utilization targets; communicates regulatory considerations to non-technical audiences as needed.QualificationsBachelor's Degree; higher degree preferred.Subject matter expertise in current regulatory frameworks for non-interventional studies, clinical trials and medical device regulations.Experience with GxPs (e.g., GVP, GCP, ISO *****) and strong knowledge of clinical research management processes, drug development,
and clinical project management.Budgeting and quality management experience; ability to mentor and coach team members.Excellent communication and interpersonal skills; able to influence and collaborate in a team environment.Quality-driven approach with strong problem-solving and negotiation skills.Continuous learning to stay current with applicable regulations and guidelines.About Syneos HealthSyneos Health is a leading biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs and commercial insights into outcomes.
We are agile and driven to accelerate the delivery of therapies and to change lives.Work here matters everywhere.
Learn more about Syneos Health.We are committed to diversity and inclusion and to equal opportunity employment.
We encourage applicants of all backgrounds and experiences to apply.
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📌 Principal Clinical Trial Regulatory Affairs - +4 Years Of Experience In Regulatory Submissions [...] (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires
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