Katalyst CRO · 14 hours ago
Principal Regulatory Affairs Manager
United States
Contract
Remote
Lead/StaffKatalyst CRO is a leading organization in the clinical oncology environment, seeking a Principal Regulatory Affairs Manager. This role is responsible for developing and executing regulatory strategies for high-complexity diagnostics, particularly Companion Diagnostics, while ensuring compliance and driving innovation in the Biopharma sector.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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