Compliance

• Collaborate with internal teams to ensure regulatory compliance for clinical trials
• Prepare and submit regulatory documents to health authorities
• Liaise with regulatory agencies and manage relationships
• Monitor changes in regulations and update policies as needed
• Provide training and guidance on regulatory matters

Principal Clinical Trial Regulatory Affairs – CTRA

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Senior Specialist, Regulatory & PV Network

• Support maintenance of Information Security Management System (ISMS), Business Continuity Management System (BCMS), AI Management System (AIMS) or other management systems are required
• Evaluate the design and effectiveness of controls and standards to ensure compliance with the applicable audits and assessments
• Assist with compliance and audit programs across multiple teams, including operations, security and product engineering
• Clearly articulate compliance programs and manage communications with internal stakeholders regarding operational processes and key controls
• Act as liaison for compliance engagements between required departments
• Assist in the management of external compliance audit activities
• Facilitate third-party management by engaging in collaborative compliance initiatives
• Develop and implement internal policies and procedures in support of compliance initiatives
• Familiarity with international standards and Software as a Service, particularly supplier management, continual improvement and business continuity
• Perform other duties and/or projects as assigned

Compliance Analyst

• Enabling customers to make the world healthier, cleaner and safer
• Join global Regulatory Affairs department, Reg Science team
• Lead discussions, coordinate regulatory strategies globally on assigned clinical trials
• Provide innovative solutions and global regulatory expertise
• Act as liaison with internal and external clients
• Arrange, lead, and report on client and regulatory agency meetings

Principal Regulatory Affairs Specialist – Global Clinical Trial Applications

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings

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Principal Clinical Trial Regulatory Affairs – CTRA

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