US-TX, Global Program Regulatory Manager - Optha Medical Device 213618BR-MZ
Global Program Regulatory Manager - Optha Medical Device
Global Drug Development
REG AFFAIRS GDD
Fort Worth, TX
Research & Development
DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the DRA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the DRA subteam and may indirectly report to the DRA GPT representative for the project and may have responsibility for leading regional DRA subteams.
Regulatory Strategy Responsible for implementing regulatory strategy and managing operational activities for assigned regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. Partners with regions to align on regulatory strategy in order to fullfill business objectives. Implements RFP across assigned regions. Works with DRA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders. Works with DRA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge. Represents DRA on or leads sub-teams as required. HA Interactions Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL. Interacts directly with HAs as appropriate in meetings with DRA GPT representative and/or GTAL. Coordinates and plans rehearsals for HA meetings. Facilitates preparation and finalization of briefing books. Develops and implements plans for timely response to HA requests and coordinates responses. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals Responsible for integrating global strategy into regional submissions worldwide. Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Contributes to development and implementation of plans to avoid/minimize clock stops during submission review. Responsible for Medical Device applications submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Participates in negotiations for approvals as required with DRA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the DRA GPT representative and/or GTAL. 2 Prescribing Information Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS)with DRA GPT representative and/or GTAL,
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Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. English Experience with regulatory submission and approval processes in 1 or more major regions. Medical Device experience strongly preferred Experience in a global/matrix environment or cross-functional teams medical device, OTC (drug product monograph) in the pharmaceutical industry. Experience in HA negotiations. 2-4 years involvement in regulatory preclinical, engineering and clinical medical device , product monographs (OTC) and drug/biologic development preclinical, engineering and clinical spanning activities in Phases I-IV in the following areas: 1. Innovation in regulatory strategy. 2. Understanding of post-marketing/brand optimization strategies and commercial awareness preferred. 3. Involvement in an dossier submissions and approvals 4. HA negotiations. 5.Medical Device submission and commercialization in region 6. Analysis and interpretation efficacy and safety data. 7. Regulatory operational expertise. Strong interpersonal, communication, negotiation and problem solving skills. Basic organizational awareness (e.g., interrelationship of departments, business priorities). 8. Regulatory operational expertise for Medical Device, OTC and pharmaceutical products. Strong interpersonal, communication, negotiation and problem solving skills. Basic organizational awareness (e.g., interrelationship of departments, business priorities).
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