Regulatory Strategy Lead Consultant
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.
Apply tot his job
Apply To this Job
• *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.
Apply tot his job
Apply To this Job