Description
We are looking for a Senior Clinical Trial Regulatory Advisor to join our team in Argentina. As a Senior Clinical Trial Regulatory Advisor, you will be 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.
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.
Requirements:
- 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), ISO 14155) etc.
- Subject matter expertise in current regulation frameworks.
- Strong knowledge of clinical research management processes.
- Excellent presentation, documentation, influencing, and interpersonal skills.
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture