Global Regulatory Leader

Vor 6 Tagen


Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit
Job Description

We are seeking a highly skilled Global Regulatory Leader to join our team. The successful candidate will be responsible for directing the development and submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.

This role requires strategic thinking and the ability to provide expert advice on regulatory matters. The ideal candidate will have a deep understanding of regulatory agencies and their requirements.

The Global Regulatory Leader will serve as a liaison between our teams and regulatory agencies, ensuring timely approval of new drugs, biologics/biotechnology, and medical devices. This includes coordinating with cross-functional teams, managing operational activities, and contributing to global regulatory strategy.

Main Responsibilities:

  • Implementing regulatory strategy and managing operational activities for assigned regions
  • Providing input into global regulatory strategy and contributing to the Regulatory Functional Plan (RFP)
  • Partnering with regions to align on regulatory strategy and implement RFP across assigned regions
  • Determining requirements and setting objectives for Health Authority (HA) interactions
  • Facilitating preparation and finalization of briefing books and contributing to summary documents
  • Developing and implementing plans for timely response to HA requests and coordinating responses
  • Serving as local HA liaison depending on location
  • Driving coordination, planning, and submission of dossiers in assigned regions worldwide

Requirements:

  • Proven track record in regulatory affairs and leadership roles
  • Strong understanding of regulatory agencies and their requirements
  • Excellent communication and negotiation skills
  • Able to work independently and collaboratively in a team environment
  • Fluency in English (both written and spoken)


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