Offre: regulatory submission publisher:Randstad.chJob description:
job detailspublié . 09. décembre 2021 lieu . basel, bâle-ville secteur . life sciences type d'emploi . contract référence . 16864 contact . audrey bisch, bâle professionals health care & life sciences téléphone . 058 201 55 50 appliquer > description du posteDo you want to work in a big pharmaceutical company? Do you have experience in regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Global Program Regulatory Manager (GPRM) for an 8 months contract. Your Tasks: Regulatory Strategy 1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions. 2. Partners with regions and the GPRD to align on regulatory strategy in order to fulfill business objectives. 3. Represents RA on or leads sub-teams as required. HA Interactions 1. Facilitates preparation and finalization of briefing books, and supports HA meetings / meeting preparation under the direction of the GPRD. 2. Develops and implements plans for timely response to HA requests and coordinates responses. 3. May serve as local HA (EMA) liaison. Submissions and Approvals 1. Responsible for integrating global strategy into regional submissions worldwide. 2. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide. 4. Review of global dossier summary documents. Responsible for preparation, review, finalization of regulatory documents for submission. 7. Participates in negotiations for approvals as required. 8. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the GPRD. Prescribing Information 1. Assists with generating local PIs and ensuring that they are integrated with the CDS. 2. Revise labels as needed to achieve timely HA approval with best possible label based on available data. 3. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL. Regional Excellence and Compliance 1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions. 2. Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system. 4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes. Your Profile: Education (Minimum/desirable): Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. · Experience with regulatory submission and approval processes in 1 or more major regions (minimum EU Centralized Procedure). · Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry. · Experience in HA negotiations. · 2-4 years involvement in regulatory and drug/biologic development. · Strong interpersonal, communication, negotiation and problem solving skills. Do not waste any minutes, apply now! We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. Skills:
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