[Hiring] Senior Country Regulatory Specialist @Syneos Health

Role Description

Perform assigned activities related to country regulatory operations. Responsible for providing delivery and expertise in country ethics and regulatory submissions from startup until project end, ensuring that activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.

• Serve as main country-level contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the direction and supervision of the Project Lead (PL), Regulatory Lead (RL), or Site Activation Manager (SAM).
• Maintain regulatory country intelligence in regulatory intelligence systems.
• May directly interact with Customers regarding requirements from RA or other local regulatory entities.
• May consult on pre-award regulatory submission strategy.
• Accountable to the PL/RL/SAM at the project level for regulatory submission and country regulatory maintenance tasks, and line manager for other country specific deliverables.

Core Responsibilities

• Responsible for providing quality deliverables at the country and site level.
• Follows project requirements and applicable country rules, with oversight at the project level from the PL/RL/SAM.
• Expert knowledge of RA/EC processes, requirements, and timelines.
• Maintain current knowledge of applicable regulations and guidelines.
• Identify relevant laws, regulations, and guidance documents covering pre-and/or post-market requirements.
• Provide country-level SME knowledge at the pre-award stage to support robust business development presentations based on the project-specific requirements and timelines of the project.
• Provide country-level SME knowledge during the site-selection process to support the selection of appropriate sites based on the project-specific requirements and timelines of the project.
• Maintain Intelligence on country specific start up timelines.
• Provide strategic recommendations to project teams.
• Forecast submission and approval timelines at the project level, track milestone progress in agreed tracking system, analyze delays, propose mitigation plans, and escalate risks appropriately.
• Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required while ensuring compliance with local regulatory requirements.
• As required by local regulations, prepare ongoing submissions to the applicable authorities for amendments, periodic notifications required by central and local EC and RA, safety notifications, and other local regulatory authorities as needed within the country.
• Directly interact with RAs and ECs, identifying solutions when issues arise.
• Coordinate, contribute to, and submit RA/EC query responses.
• When necessary, influence RA/ECs via local CRO associations.
• Serve as the country-level regulatory SME point of contact through the life of assigned projects.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) in compliance with SOPs and Customer requirements.
• Serve as country level regulatory SME maintaining country intelligence in regulatory intelligence systems, contributing and validating information as the scope of the regulatory intelligence system expands.
• Complete/contribute to Regulatory Impact Assessments and implement Operational Actions as regulations change.
• Develop or support the creation of local country regulation training materials.
• Support training and mentoring more junior Country Regulatory Specialists.
• When required, provide SME knowledge and support to the Syneos Health Procurement team in managing Ethics/IRB vendors.
• Ensure continuous improvement of quality in all components at the country level where assigned (submissions, communication to Competent Authorities and ECs, etc.).
• Provide input to SOPs and WIs.
• Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting.
• Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner.

Qualifications

• Minimum of a BA or BS preferred.
• 5-6 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience that provides the necessary knowledge, skills and abilities to perform this job.
• Detailed understanding of clinical trial process across Phases I-IV and ICH GCP.
• Detailed understanding of clinical trial submission processes per-country and local regulations.
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc.
• Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality.
• Strong presentation, documentation, influencing, and communication skills (both written and spoken) as well as a team-oriented approach.
• Knowledge and interpersonal skills necessary to effectively train and mentor more junior Country Regulatory Specialists.
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary.
• Ability to manage competing priorities and work in a dynamic fast-paced environment.
• Demonstrated ability to work independently as well as part of a team.

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.
• We are continuously building the company we all want to work for and our customers want to work with.