Principal Regulatory Solutions Architect

Job Description
This is a unique opportunity to contribute to envisioning, creating, and delivering authorized cloud solutions built on the DNAnexus global platform and change the paradigm for interaction between global pharmaceutical companies, and international regulators and patient advocacy groups. You will work directly with the FDA and other international regulators, global pharmaceutical companies, large systems integrators, and patient advocacy groups to advance a wide range of regulatory science and review objectives, while directly contributing to growing Regulatory Solutions revenue and company value.
You will be an expert representative for precisionFDA, working with the DNAnexus Chief Cloud Officer and precisionFDA Program Director and Engineering Team to envision new and enhanced capabilities, and to drive the strategic scientific research and regulatory advancement projects that are rapidly extending DNAnexus' reach into the international regulatory space.
Your work will cover a wide range of disciplines and there will be many opportunities to learn.
Your world in acronyms will encompass (but not be limited to) FISMA, FedRAMP, ISO-9001, GDPR, GxP, 21 CFR Part 11, QMS, HL7, CDISC, SDTM, OMOP, FHIR, BAM, FASTQ, VCF, DNA-seq, RNA-seq, scRNA-seq, HRD, TMB, I-O, TCR, BCR, FOCR, OCE, DIA, CBER, CDER, CDRH, ODAR, EMA, MHRA, ICMRA, ICH, DIA, AWS, MSFT....
Who We’re Looking For
The following leadership principles () are highly valued for this role, in priority order:
Customer Obsession
Bias for Action
Learn and Be Curious
Dive Deep
Insist on the Highest Standards
Deliver Results
Are Right, A Lot
Demonstration of the above will support the other high valued principle for this role, Earn Trust.
You are fanatical about creating a delightful customer and partner User Experience (UX). UX quality is foundational to all the work that you do regardless of whether it is scientific, technical, or contractual. You leverage your coding and media production skills to enable users and developers to independently gain maximum value with minimal effort.
Security, privacy, and compliance are paramount in all your interactions, designs, and deliverables.
You are adept in creating new value from existing capabilities and developing profitable solutions by packaging up current products in a novel manner.
You can sell your ideas and solutions and create real business value from them. You have no problem getting hands-on and testing your ideas in the cloud. You are revenue, profit, and growth focused and understand how your work contributes to company objectives.
You are an outstanding problem solver and researcher and are able to independently resolve issues and blockers to successfully deliver on commitments.