Global Regulatory Leader
Vor 6 Tagen
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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