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 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 Solutions

Through 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/biopharma

Your Mission

Reporting 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 vale you bring

• Provide strategic regulatory guidance for CDx collaborations with BioPharma partners, and work closely with the BioPharma business team on strategic initatives 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.

Requirements

We know the 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 programms 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 commercialised, risk-aware approach to drive development and partnerships forward

As a public organisation facing ongoing commercial growth, you will bring a success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion.

Benefits

You will be joining an organisation 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 Startup
• Top 10 European biotechs startup to watch
• Top 25 East-Coast Biotech to watch

Our 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 r