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Clinical Regulatory Specialist
Syneos Health. Perform assigned activities related to country regulatory operations under supervision .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in country regulatory operations and clinical trial submission processes, ensuring compliance with local regulations and ICH GCP standards. Proven ability to manage timelines, communicate effectively with regulatory authorities, and contribute to quality improvement in submissions.
Highest-signal resume keywords
Clinical Trial ProcessesRegulatory SubmissionsICH GCPGxP ComplianceRegulatory Intelligence Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory Submission StrategyRegulatory Impact AssessmentsClinical ResearchCountry-Specific Startup TimelinesDocument Submission Compliance
Soft Skills
Organizational SkillsProblem-Solving SkillsCommunication SkillsTeam-Oriented ApproachPresentation Skills
Tools & Technologies
Microsoft Office SuiteWeb-Based SystemsTrial Master File
Industry Keywords
Clinical TrialsPhases I-IVGVPISO 14155Ethics Committees
About the role
Key responsibilities & impact- Perform assigned activities related to country regulatory operations under supervision
- Provide delivery and expertise in country ethics and regulatory submissions from study startup through project end
- Serve as the main country-level contact with Regulatory Authorities and Central/Regional Ethics Committees
- Maintain regulatory country intelligence in regulatory intelligence systems
- Interact with customers regarding requirements from Regulatory Authorities and local regulatory entities
- Consult on pre-award regulatory submission strategy
- Provide country-level regulatory subject matter expertise during business development and site selection
- Maintain intelligence on country-specific startup timelines and provide strategic recommendations
- Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
- Prepare and submit Central EC, Local EC, Regulatory Authority, hospital approval, amendment, periodic notification, safety notification, and other local submissions
- Interact directly with Regulatory Authorities and Ethics Committees and coordinate query responses
- Serve as country-level regulatory SME throughout assigned projects
- Ensure relevant documents are submitted to the Trial Master File in compliance with SOPs and customer requirements
- Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change
- Develop or support local country regulation training materials
- Support Procurement in managing Ethics/IRB vendors when required
- Ensure continuous quality improvement in country-level submissions and communications
- Review and comply with SOPs and Work Instructions, maintain training compliance, and submit accurate timesheets
- Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies
Requirements
What you’ll need- Minimum of a BA or BS preferred
- 3-4 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience
- Detailed understanding of clinical trial processes across Phases I-IV and ICH GCP
- Detailed understanding of clinical trial submission processes per country and local regulations
- Experience working to applicable GxPs, e.g. GVP, GCP, ISO 14155
- Strong organizational and problem-solving skills
- Proven ability to meet deadlines with high quality
- Strong presentation, documentation, influencing, and communication skills, both written and spoken
- Team-oriented approach
- Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, email, and Internet
- Ability to manage competing priorities and work in a dynamic, fast-paced environment
- Demonstrated ability to work independently and as part of a team
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture focused on employee authenticity and belonging
- Reasonable accommodations for employees or applicants with disabilities, when appropriate