Global Regulatory Lead for Clinical Trials

Syneos Health, Inc.; Tandil; Sur place; ARS 185 966 000 - 247 954 000; Plein temps

Résumé du poste

Syneos Health in Argentina seeks a Senior Clinical Trial Regulatory Advisor to lead regulatory deliverables across countries and lifecycles. The role involves preparing submission strategies, coordinating CTIS uploads, and aligning with project leadership on milestones and client expectations.

The successful candidate will bring deep regulatory knowledge and strong communication skills to manage complex submissions, risk assessments, and client relations in a fast-paced, global environment.

Qualifications

• Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
• Subject matter expertise in current regulation frameworks (e.g., 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.

Responsabilités

• 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 and reports progress including plans to address potential risks/gaps to the project team, PM, Site Activation Management and Sponsor.
• 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 including regulatory assessment, updates plans, preparing submission strategy, reviewing core documents, coordinating regulatory submissions, and performing study level tracking.
• 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.
• Maintains current knowledge of applicable regulations and guidelines and ensures all relevant documents are submitted to the TMF as per SOPs.
• Explain complex regulatory issues into plain language to nontechnical audiences.

Connaissances

Regulatory expertise

GxP knowledge

Clinical project management

Communication skills

Teamwork

Negotiation skills

Formation

Bachelor’s Degree, Higher Degree Preferred.

Description du poste

Syneos Health in Argentina seeks a Senior Clinical Trial Regulatory Advisor to lead regulatory deliverables across countries and lifecycles. The role involves preparing submission strategies, coordinating CTIS uploads, and aligning with project leadership on milestones and client expectations.

The successful candidate will bring deep regulatory knowledge and strong communication skills to manage complex submissions, risk assessments, and client relations in a fast-paced, global environment.