Katalyst CRO
Principal Regulatory Affairs Manager
Katalyst CRO, Jacksonville, Florida, United States, 32290
Overview
The
Principal Regulatory Affairs Manager
role at
Katalyst CRO
focuses on regulatory strategy development and execution for high-complexity diagnostics, specifically Companion Diagnostics and digital pathology in the clinical oncology environment. This position is fully remote and reports to the Director, Regulatory Affairs. Responsibilities
Lead regulatory strategy and execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards. Maintain regulatory intelligence and execute regulatory plans, updating internal procedures to reflect evolving US and international regulations. Assess the impacts of relevant drug and diagnostic regulations on development and registration activities for the respective medical products. Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals. Collaborate cross-functionally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with business and clinical goals, providing device-specific regulatory guidance during CDx / Pharma partner meetings. Demonstrate a proven track record in supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions. Develop and document regulatory strategies in coordination with clinical plans and marketing objectives. Requirements
Bachelor’s, Master’s, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Extensive experience with cross-functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions. Ability to communicate regulatory strategy, issues, and risks to regulatory senior leadership and other governing bodies in written and verbal form. Strong understanding of Global Regulatory Strategy roles and deliverables in Drug and Device Development and Commercialization. Experience applying advanced regulatory expertise to support global development and commercialization of complex, high-risk products, with both immediate challenges and long-term strategic outcomes. Experience leading cross-functional teams in a matrixed environment, ensuring timely decision-making and alignment across global stakeholders. Experience with drug development and drug regulatory procedures. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Regulatory Affairs Manager jobs in Jacksonville, FL.
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The
Principal Regulatory Affairs Manager
role at
Katalyst CRO
focuses on regulatory strategy development and execution for high-complexity diagnostics, specifically Companion Diagnostics and digital pathology in the clinical oncology environment. This position is fully remote and reports to the Director, Regulatory Affairs. Responsibilities
Lead regulatory strategy and execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards. Maintain regulatory intelligence and execute regulatory plans, updating internal procedures to reflect evolving US and international regulations. Assess the impacts of relevant drug and diagnostic regulations on development and registration activities for the respective medical products. Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals. Collaborate cross-functionally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with business and clinical goals, providing device-specific regulatory guidance during CDx / Pharma partner meetings. Demonstrate a proven track record in supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions. Develop and document regulatory strategies in coordination with clinical plans and marketing objectives. Requirements
Bachelor’s, Master’s, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Extensive experience with cross-functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions. Ability to communicate regulatory strategy, issues, and risks to regulatory senior leadership and other governing bodies in written and verbal form. Strong understanding of Global Regulatory Strategy roles and deliverables in Drug and Device Development and Commercialization. Experience applying advanced regulatory expertise to support global development and commercialization of complex, high-risk products, with both immediate challenges and long-term strategic outcomes. Experience leading cross-functional teams in a matrixed environment, ensuring timely decision-making and alignment across global stakeholders. Experience with drug development and drug regulatory procedures. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Regulatory Affairs Manager jobs in Jacksonville, FL.
#J-18808-Ljbffr