Job Description

Global Regulatory Support SharePoint Maintenance Activities; Trigger annual review of Regulatory Strategy Plan; Maintain HA engagement plan Support GRT member transition by setting up transition form Execution of Regulatory Strategy Liaise cross-functionally to generate periodic internal milestone report Communicate status and timeline changes Tracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc Regulatory Intelligence Monitors key Health Authority Websites for pertinent information Compiles Regulatory precedents as requested Global Regulatory Submissions Support Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process Support of Divestitures / Product Deletions / Product Termination / Asset Integration Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy Interacts with Global Product Development & Supply (Last batch expiry) to ensure timely reporting to the respective Health Authority(ies) Maintain database for Product Deletion Requirements HA queries / Shortage Notifications Schedule RRT meetings and communicate timelines Set up response templates to ensure submission readiness Submission of responses for publishing Analytics / Compliance Activities Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones Review Verity and Infinity reports for Compliance related trends, eg HA commitments, Development commitments, open CAPAs, CAPAs coming due Degree Requirements Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field Qualifications/Requirements: 2years in pharmaceutical industry and regulatory experience Key Competency Requirements Solid understanding of at least one major Health Authority (FDA, EMA, MHRA) regulations and Regulatory standards Act as a role model & set a good example Identify, communicate and propose resolutions to routine/complex issues. Articulate the implication of issue to project team on risk/benefit strategic component.Establish strong working relationsships Good communication and organizational skills and a meticulous eye for details Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation. Ability to make decisions in their sphere of influence Independently work on multiple projects & assignments. Ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline. Must possess an excellent command of language (English) Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities

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