4 Regulatory Submission Jobs

Corporate Title: Assistant Vice President To comply with both US and Global regulations, the Financial Market Infrastructure (FMI) Operations team must ensure there are Contingency Strategy (CS) documents in place for all material relationships held with FMIs and Agent Banks, to support continued access to key services in a stress scenario. The CS document describes the actions which could be taken by the FMI and how the DB Group could respond, ahead of and during resolution. To determine which relationships require a CS, an annual global data collection is coordinated by the FMI Operations team, which drives a materiality assessment to determine the key relationships for the DB group. The creation/refresh of a CS involves being able to review and interpret global regulatory guidance, to ensure the CS is adapted to evolving requirements. The team also engage with Business, Operations, Treasury, Legal, and Risk Management functions to gather their feedback and input. Your key responsibilities Support the completion of the annual data gathering outreach, including data validation / review. Analyze and interpret regulatory guidance and enhance existing contingency strategies to meet regulatory requirements. Independently manage the review/creation of multiple CSs for FMIs / Agent Banks ensuring a high and consistent standard of quality. Effectively manage communication, feedback and approval from internal senior stakeholders. Perform quality and consistency reviews of contingency strategies. Provide support for the Team lead / process oversight and governance. Your skills and experience Excellent reading and writing skills, with ability to independently draft new documentation suitable for regulatory submission. Strong ability to scrutinise extensive documentation, review and interpret regulatory guidance, to incorporate to the CS. Analytical and communications skills; effectively host meetings with multiple stakeholder groups including senior management/external audiences. Confident data review, analysis and presentation (pivots/v-lookup/text functions/formulas/SharePoint/PowerPoint/Excel) with high and consistent attention to detail. Ability to prioritise and effectively manage workload across multiple workstreams, working within tight time frames, providing accurate updates, escalations and highlighting remedial actions. Desirable to have; Understanding of Living Wills / Recovery and Resolution Planning and other applicable regulations. Understanding of the operations and functions of clearing houses, central securities depositories, and payment systems. Understanding of securities & cash products. Previous operational (settlement and clearing) industry experience Team or process lead/management experience

1) Review and compilation of ANDS Module 1 to Module 4 2) Review and compilation of SANDS 3) Review and compilation of labelling documents 4) Compilation and submission of applications using eCTD software

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical. Stay updated with global regulatory guidelines (ICH, FDA, EMA). Detail-oriented with a collaborative mindset. Minimum Qualifications and Experience B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Minimum 4 to 8 years Preferred Qualifications/ Skills Proficiency in managing Regulatory eCTD Submission for all Global Markets. Good knowledge on eCTD Guidance and understanding validation criteria requirement. Strong communication and interpersonal skills. Experience with electronic submission (New Development Product Filings / LCM). Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously. High level of attention to detail and accuracy in document level publishing and submission compilation/validation. Ability to work collaboratively in a cross-functional team environment. Proficiency in using regulatory databases, information management systems, and other relevant software tools. Commitment to staying updated on regulatory changes and advancements in the field.

Reporting Structure Reports to Manager Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly information system. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities. Prepare for internal or external audits and inspections. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities. Essential Qualification Bachelors/ Masters degree in Pharmacy Competencies Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint