Director, Regulatory Affairs

Do you have expertise in Companion Diagnostics, Clinical Trial Assays and Associated BioPharma Programmes, and bring a background in regulatory frameworks within Oncology or Rare Diseases? Do you want to be at the forefront of innovation, as we pioneer a movement to elevate standards of care globally, breaking barriers so health knows no limits?If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Regulatory Team as Director, Regulatory Affairs , and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.Ideally, you will be in proximity to our Boston Fenway office; however, suitably qualified candidates can be considered on a remote basis in the US-North East. Due to high collaboration and team structure within Europe, this role wouldn't suit someone working remotely from the US West Coast.Our Mission - BioPharma SolutionsThrough a decentralized global network and patented algorithms, we give the BioPharma community access to high quality NGS solutions leveraging the SOPHiA DDM platform, including highly anticipated ctDNA-based solution in partnership with world-leading Academic Medical Center Memorial Sloan Kettering (MSK).MSK ACCESS powered with SOPHiA DDM will be made available to BioPharma organisations to support R&D efforts, clinical trials and patients on a global scale.Learn more about SOPHiA DDM BioPharma Solutions here : https : / / www.sophiagenetics.com / biopharmaYour MissionReporting directly to the EVP, Chief Legal & Regulatory Officer, this role works cross-functionally with internal teams, external BioPharma Partners, and CROs to drive regulatory excellence.The value you bringProvide strategic regulatory guidance for CDx collaborations with BioPharma partners, and work closely with the BioPharma business team on strategic initiatives related to regulatory approvals and market access.Drive efforts to secure regulatory designations and contribute to CDx strategy development and submissions.Oversee and manage submissions for premarket approvals (PMAs), CTAs, IDEs, and other global regulatory filings.Represent SOPHiA GENETICS in regulatory meetings, including pre-submission meetings, advisory committees, and consultations with global health authorities.Provide regulatory intelligence, informed of evolving global regulatory landscapes, including changes in guidance related to IVD products, NGS, CDx, SaMD, and precision medicine.We know that every background is different, but to be best set for success we see you bringing : 10 years of Regulatory Affairs experience in the pharmaceutical or diagnostics industry, including 5 years in IVD.Proven track record of successful diagnostics regulatory submissions (e.g., PMAs, 510(k)s, IDEs, CTAs).Direct working knowledge of CDx, CTA and Associated BioPharma programs is critical - ideally this will include NGS Diagnostics, but may include wider Dx including PCR.Comprehensive knowledge of drug and diagnostic development processes, with the ability to interpret and apply regulatory guidance flexibly and strategically.Knowledge of Oncology regulatory frameworks highly valuable.A commercialized, risk-aware approach to drive development and partnerships forward.As a public organization facing ongoing commercial growth, you will bring a success-oriented and solutions-focused mindset that embraces team collaborations, change, growth, and inclusion.You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.Business recognition and accolades include : World's most innovative companies (Top 10)World's smartest companies (Top 50)100 Best Places to Work in Boston (2022-2025)Top 10 European Tech StartupTop 10 European biotechs startup to watchTop 25 East-Coast Biotech to watchOur US benefits package is comprehensive, but varies internationally in line with local standards and laws. You can discuss a full breakdown with us, but as a brief overview : Outstanding Medical (with Telemedicine), Dental, and Vision Plan with 90% employer contributions, including $0 deductible plans options.Life and AD&D company provided.Company 4% match 401K contributions.Company-paid Short and long-term disability insurance.20 Days PTO (Increases with tenure), 5 sick days and 13 Public holidays recognized.FSA commuter benefits.Supplemental employee insurance options are available for Accident, Critical Illness, Hospital and Legal.Voluntary Pet Insurance and Auto and Home options.Employer Assistance Program free for all employees.Our DNALike the strands of DNA itself, SOPHiA GENETICS and the team are deeply interconnected and reliant on each other to deliver. There are common threads across the team. Things that bind us together. Those things are Relentlessly Curious; Resilient & Nimble; and Fearlessly Adventurous.Our VirtuesAt SOPHiA GENETICS we established our 7 Virtues to clarify how our principles show up each day through action. We Decide; We Do; We Collaborate; We Innovate; We Empower; We Adapt; and We Learn.At the center of our Virtues is our Mantra, We Care, which provides a constant reminder of the compassionate, benevolent, and hopeful nature of our mission and how it should be threaded through each of our Virtues and everything we do. Learn more about our DNA and Virtues on our Careers portal.The processWe use the power of AI to help our partners make decisions. If you’re utilizing AI in your search and application process, why not use some of these prompts : ‘What impact can I expect to have on the world by working at SOPHiA GENETICS?’‘I have an interview with SOPHiA GENETICS. What should I know before I meet with them?’‘I am a

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• What can SOPHiA GENETICS offer my career?’Apply now with your CV and any supporting information.Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholders from across the business. If you need additional support for accessibility, please contact our TA team for assistance.We appreciate the value external partners can bring, but we operate a direct-hiring model and we are not looking to utilize agency support at this time. All hiring is controlled by Talent Acquisition, potential partners should liaise through TA and not our hiring teams please.Starting Date : ASAPLocation : Boston, MA (Hybrid) or US North East Remote-HybridContract : Permanent#J-18808-Ljbffr