Job Description
- Our
- *On-Demand Talent Solutions**
- group is excited to share this fantastic consulting opportunity. We are seeking passionate, skilled
- *Regulatory Strategy Lead**
- professionals interested in making an impact in a dynamic organization.
- *Summary:**
- The Regulatory Strategy Lead Consultant will be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally. Serves as a regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development and regulatory requirements. Develops and implements accelerated submission strategies.
- *Responsibilities:**
- Leads the GRT to development of creative global strategies in line with applicable. regulations to achieve business objectives for development and marketed products.
- Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
- Key internal leader and driver of regulatory policy and strategy for assigned products.
- Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
- Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
- *Qualifications:**
- Advanced degree with at least 10 years of industry experience.
- Must have Oncology experience
- Experience as a lead regulatory strategist in two or more major regions.
- Strong global drug development foundation with business acumen.
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