Principal Clinical Trial Regulatory Affairs, +4 Years Experience in Regulatory Submissions in LATAM
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Job Description
Principal Clinical Trial Regulatory Affairs role requiring expertise in LATAM regulatory submissions. Responsibilities include strategic development activities and line management for staff members.
Responsibilities:
- 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.
- Line management responsibilities for staff members. For direct and indirect reports, 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.
- Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
- Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.
- Maintain current knowledge of applicable regulations and guidelines.
Requirements:
- +4 years of experience in regulatory submissions in LATAM - Argentina, Mexico or Brazil
- 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.
- 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.
Benefits:
- 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.
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