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Principal Clinical Trial Regulatory Affairs, +4 years experience, multiple countries
Syneos Health. Support customer-focused leadership and management of CTRA deliverables within assigned projects or programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions and compliance within clinical trials, including the ability to manage project deliverables, mentor team members, and communicate complex regulatory issues effectively. Proficient in developing strategic customer relationships and ensuring adherence to quality standards and regulatory frameworks.
Highest-signal resume keywords
Regulatory Submissions ManagementClinical Trial ComplianceGxP Knowledge (GVP, GCP, ISO 14155)Budgeting and Quality ManagementTeam Leadership and Mentoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document AuthoringRegulatory Impact AssessmentsClinical Research ManagementRisk Mitigation PlanningSubmission Package TrackingRegulatory Assessment CompilationProject Budget ManagementStrategic Execution PlanningRegulatory Framework ExpertiseClinical Trial Regulation Knowledge
Soft Skills
Excellent Communication SkillsInterpersonal SkillsProblem-Solving SkillsNegotiation SkillsTeam-Oriented Approach
Tools & Technologies
CTISRegulatory Submission ToolsProject Management Software
Industry Keywords
Clinical TrialsNon-Interventional StudiesMedical DevicesRegulatory ComplianceQuality Standards
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support customer-focused leadership and management of CTRA deliverables within assigned projects or programs
- Contribute to technical and operational aspects of CTRA deliverables
- Develop and maintain strategic customer relationships and proactively assess client needs
- Compile core packages, complete regulatory assessments and submission forms, and upload documents to CTIS
- Report progress, risks, gaps, and mitigation plans to project teams, Project Managers, Site Activation Management, and Project Sponsors
- Collaborate as a Regulatory Subject Matter Expert with functional area leads on Site Activation pathways
- Participate in strategic account and portfolio client meetings
- Manage line-management activities including hiring, professional development, performance management, coaching, mentoring, and employee administration
- Ensure project deliverables meet internal and customer expectations, including projections, reports, updates, and risk assessments
- Define execution strategies for milestones and key deliverables with project leadership
- Prepare and present regulatory and submission strategies and status at client meetings
- Review clinical trial study core documents for regulatory compliance
- Coordinate and perform regulatory submissions, including EU Clinical Trial Regulation Part I dossiers, and track submission packages
- Analyze Competent Authority and Ethics Committee regulatory considerations and Requests for Information
- Author regulatory documents for submission when required
- Prepare amendment and modification dossiers throughout project life cycles
- Oversee country-specific application collation, quality review, and submission
- Perform regulatory impact assessments, identify gaps, and communicate risk mitigation
- Review project budgets against milestones and manage scope, profitability, and out-of-scope work
- Act as liaison between customer leaders and senior management on regulatory tasks and issues
- Explain complex regulatory issues to nontechnical audiences
- Lead regulatory activities for projects with complex regulatory profiles
- Facilitate CTRA team processes and communications
- Support business development, proposal reviews, conferences, and strategic account activities
- Support project and departmental review meetings
- Develop and deliver departmental training programs and presentations
- Transfer knowledge to entry-level employees and apply technical expertise in multidisciplinary teams
- Maintain compliance with quality standards, utilization targets, regulations, laws, and guidance documents
Requirements
What you’ll need- Bachelor’s Degree required; higher degree preferred
- +4 years of experience with multiple countries regulatory submissions
- Subject matter expertise in current regulation frameworks, including regulations and guidelines for non-interventional studies, clinical trials, and medical devices
- Experience working to applicable GxPs, including GVP, GCP, and ISO 14155
- 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 and mentor team members
- Ability to coach employees to reach performance objectives
- Ability to recognize and act when employee performance is unacceptable
- Excellent written and spoken communication and interpersonal skills
- Team-oriented approach
- Quality-driven approach
- Strong negotiating and problem-solving skills
- Ability to provide quality feedback and guidance to peers
- Equivalent experience, skills, and/or education may be considered
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations for applicants with disabilities