Compliance

• Act as a key interface between Sales, Bid Managers, Legal, Finance, and Delivery teams.
• Manages approvals in a timely and effective manner; ensures approvers and approver levels/routes are accurately identified as per the rules; determines necessary deal documentation requirements; ensure the documentation is completed, accurate, and aligned across systems
• Identify gaps, inconsistencies, and risks, and actively follow up with Sales and Bid teams to close them before approval decisions.
• Support approval decision readiness by validating that all required questions are answered and evidence is available.
• Escalate critical compliance issues and “show‑stoppers” to Bid Management Leads and reviewers.
• Ensure leadership and required stakeholders are informed in line with approval level requirements and timelines.
• Ensure all relevant functions are engaged at the right time and their inputs are captured and reflected correctly.
• Drive and maintain Opportunity Compliance Checklists and related questionnaires across the sales and bid lifecycle.
• Support continuous improvement by proposing updates to compliance matrices, templates, and processes.
• Apply consistent scoring, readiness indicators, and status reporting to support go / no‑go decisions.
• Highlight commercial, contractual, and operational risks based on policy deviations, data misalignment, or incomplete inputs.
• Works with the stakeholders inside and outside of the business unit to ensure the deal approval completion
• Supports internal and external auditing activities with relevant information and data
• Support bid lead with data analytic in relation to Bid Loss/Wins; TCVs per region etc.

Compliance Analyst

• Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities in alignment with submission strategy
• Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation
• Organize submission team meetings and facilitate effective communication among all stakeholders
• Open required records in submission planning tools and Regulatory Information Management Systems
• Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements
• Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness
• Provide regular updates to the submission team on status and timelines
• Draft M1 documents as required and coordinate their review with LRR or RPR
• Support labeling preparation
• Upload M1 documents in archiving system

Senior Regulatory Affairs Associate – Regional Submission Coordinator

• 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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