Global Regulatory Strategy Director
Vor 4 Tagen
About the Job
This role will oversee the development and implementation of global regulatory strategies for our product portfolio, ensuring timely submissions and approvals with the best possible labels based on available data.
Key Responsibilities:
- Develop and implement global regulatory strategies to achieve business objectives.
- Partner with regions to align on regulatory strategy and implement RFP across assigned regions.
- Determine requirements and set objectives for Health Authority (HA) interactions.
- Facilitate preparation and finalization of briefing books and contribute to summary documents.
- Develop and implement plans for timely response to HA requests and coordinate responses.
- Drive coordination, planning, and submission of dossiers in assigned regions worldwide.
- Review global dossier summary documents.
- Develop and implement plans to avoid/minimize clock stops during submission review.
- Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Reviews and submits Risk Management Plans.
Requirements:
- Functional breadth with experience in operations management, project management, and cross-cultural collaboration.
- Clinical trials, drug development, lifesciences, negotiation skills, and regulatory compliance.
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