Collaborates 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.
May participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team.
Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.

+4 years of experience in regulatory submissions in LATAM
Bachelor’s Degree, Higher Degree Preferred.
Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non interventional studies, clinical trial and medical device regulations)
Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc
Strong knowledge of clinical research management processes.
Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
Previous experience in budgeting and quality management
Ability to teach/mentor team members.
Ability to coach employees to reach performance objectives.
Ability to recognize and take appropriate action when employee performance is not acceptable
Excellent communication and interpersonal skills (both written and spoken) with an ability to influence, convince and persuade as well as a team-oriented approach.
Quality-driven in all managed activities
Strong negotiating and problem-solving skills.
Demonstrate an ability to provide quality feedback and guidance to peers.

Principal Clinical Trial Regulatory Affairs, LATAM

Key skills