Principal Clinical Trial Regulatory Affairs
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Job Description
Principal Regulatory Affairs specialist leading complex clinical-trial submissions for Syneos Health, a global biopharmaceutical services organization. Managing regulatory strategy, dossiers, compliance, budgets, and client relationships across study lifecycles.
Responsibilities:
- Collaborate as a Regulatory Subject Matter Expert with major functional area leads on Site Activation pathway issues.
- Participate in strategic account and portfolio client meetings.
- Develop and maintain strategic customer relationships and proactively assess client needs.
- 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 strategy and status at client meetings.
- Update plans and compile controlled document requirements in accordance with SOPs and sponsor processes.
- Review clinical trial study core documents for regulatory compliance.
- Coordinate and perform regulatory core submissions, including EU Clinical Trial Regulation Part I dossiers, and track submission packages.
- Analyze CTA Competent Authorities/Ethics Committees regulatory considerations and Requests for Information.
- Author regulatory documents for submission when required and agreed with the Sponsor.
- Prepare clinical trial application dossiers for amendments and modifications throughout project lifecycle maintenance.
- Perform Regulatory Impact Assessments, identify gaps, and communicate risk mitigation to Sponsors and project teams.
- Oversee collation, quality review, and submission of country-specific applications.
- Identify gaps in evidence supporting submissions and contribute to regulatory recommendations and decisions.
- 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.
- Translate complex technical regulatory issues into plain language for nontechnical audiences.
- Lead regulatory activities for projects with highly complex regulatory profiles.
- Facilitate processes and communications within the CTRA team.
- Contribute to new business development, proposals, and strategic client activities.
- Support management in project and departmental review meetings.
- Develop and deliver training programs and courses.
- Transfer knowledge to entry-level employees and provide technical expertise in multidisciplinary teams.
- Maintain compliance with quality standards, utilization targets, applicable regulations, and guidance documents.
Requirements:
- Bachelor’s Degree required; higher degree preferred.
- Subject matter expertise in current regulatory 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 take appropriate action when employee performance is unacceptable.
- Excellent written and spoken communication and interpersonal skills, with ability to influence, convince, and persuade.
- Team-oriented approach.
- Quality-driven approach to managed activities.
- Strong negotiating and problem-solving skills.
- Ability to provide quality feedback and guidance to peers.
- Maintain current knowledge of applicable regulations, laws, and guidance documents covering pre- and/or post-market requirements for healthcare products.
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Career paths and employment opportunities
- Team collaboration with specialized therapeutic or functional teams
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