Bachelor's, Master's, or PhD in a scientific or engineering discipline
In-depth knowledge of FDA and EU regulations for Companion Diagnostics (CDx)
Extensive experience developing companion diagnostics and devices with cross-functional teams
Proven track record in executing regulatory strategies for complex diagnostic products
Solid communication skills for articulating regulatory strategies to senior leadership
Understanding of Global Regulatory Strategy roles in the Drug and Device Development process
Expertise in supporting commercialization of high-risk products
Responsibilities
Develop and execute regulatory strategy for high-complexity diagnostics in clinical oncology
Lead global submissions for CDx trials and product commercialization
Engage with Biopharma partners to form and implement regulatory strategies
Steer regulatory strategy for new product development and initiatives
Guide regulatory activities to ensure compliance and facilitate commercialization
Maintain regulatory intelligence and update internal procedures based on evolving regulations
Collaborate cross-functionally to align regulatory plans with business goals
Benefits
Fully remote position
Opportunity to mentor and lead in a global regulatory environment
Engagement with innovative projects in the Biopharma sector
Exposure to high-complexity diagnostic products
Collaboration with cross-functional teams across the globe
Full Job Description
Responsibilities:
The Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment
The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and submissions to support product commercialization in multiple regions (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA) and will mentor the organization in these key activities
The Principal Regulatory Affairs will work with Biopharma partners to develop and deploy CDx regulatory strategies
In this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives
By guiding regulatory activities, this role ensures smooth global commercialization and compliance, driving innovation and excellence in the Biopharma sector
This position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote
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, and ensure internal procedures are updated to reflect evolving US and international regulations
ssess the impacts of relevant drug and diagnostic regulations on the 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 and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to, business and clinical goals
Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings
Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions
Experience with developing and documenting 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 working 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
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required.
Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
pplying advanced regulatory expertise to support the global development and commercialization of complex, high-risk products, with a focus on both immediate challenges and long-term strategic outcomes.
Leading cross-functional teams in a matrixed environment, ensuring timely decision-making, issue resolution, and alignment across global and culturally diverse stakeholders
Experience with drug development and drug regulatory procedures.
