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.
- Assess 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.
- Applying 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.
Job Tags
Immediate start, Remote work,