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Global Program Regulatory Manager (GPRM) 100% (F/M/D) [34244]

Nemensis AG

 
Basel-Stadt
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Nemensis AG
Global Program Regulatory Manager (GPRM) 100% (F/M/D) [34244]

At nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Basel, we are looking for a Global Program Regulatory Manager (GPRM) (f/m/d).

Position purpose:

The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPRD and GTAL. The GPRM is a member of the RA sub team, and may have responsibility for leading regional RA sub teams.

Your responsibilities:

  • Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
  • Partners with regions and the GPRD to align on regulatory strategy in order to fulfill business objectives.
  • Represents RA on or leads sub-teams as required.
  • Facilitates preparation and finalization of briefing books, and supports HA meetings / meeting preparation under the direction of the GPRD.
  • Develops and implements plans for timely response to HA requests and coordinates responses.
  • May serve as local HA (EMA) liaison.
  • Responsible for integrating global strategy into regional submissions worldwide.
  • Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide.
  • Review of global dossier summary documents. Responsible for preparation, review, finalization of regulatory documents for submission.
  • Participates in negotiations for approvals as required.
  • Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the GPRD.
  • Assists with generating local PIs and ensuring that they are integrated with the CDS.
  • Revise labels as needed to achieve timely HA approval with best possible label based on available data.
  • 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. 
  • Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
  • Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system.
  • 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. 
  • 2-4 years involvement in regulatory and drug/biologic development.
  • Languages: Fluency in English as a business language. Additional language is an asset.
  • 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.
  • Strong interpersonal, communication, negotiation and problem solving skills.

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Nemensis AG

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