Director, Regulatory Affairs and Quality Assurance
2 months ago
Job type: Full-time
Hiring from: USA Only
Category: Finance / Legal
Recent progress in artificial intelligence coupled with a growing resource of longitudinal patient data from historical clinical trials and real world sources provides an unprecedented opportunity to transform clinical trials and speed the development of new medicines.
Unlearn is a science-first company that has invented the first machine learning platform for creating Digital Twins of patients in clinical trials — comprehensive simulations that answer “what would likely happen to this patient if he/she were randomized to the control group?”.
Using information from Digital Twins to estimate treatment effects reduces required sample sizes, increase statistical power, and provides patient-level treatment response information.
It's about increasing confidence in trial results.
It's about bringing new medicines to patients faster.
It's about time.
Your role at Unlearn
Are you interested in the unique opportunity to shape the use of novel technologies in clinical trials?
Unlearn.AI pioneers computational methods to help patients get life-saving therapies more quickly. As an early employee at Unlearn, you will have the opportunity to shape the regulation of AI-based drug development tools.
You will help define Unlearn's regulatory strategy and lead all initiatives related to regulatory affairs and our quality management system. Not only will your work be company defining, it will be industry defining. You will have the opportunity to bring one of the first applications of an AI-based drug development tool through regulatory review and to drive changes in the drug development process that will have wide ranging effects on the industry.
Day-to-day work will include:
- Defining and executing Unlearn's overall regulatory strategy including regulatory submissions, and advocating for policy changes.
- Serving as the point of contact for external regulatory consultants and counsel, for regulatory questions associated with client interactions, and for regulatory authorities such as FDA and EMA
- Writing, reviewing, and editing regulatory documentation, ensuring it is fit for purpose, and serving as a resource for regulatory document authors regarding the appropriate content of submissions
- Acting as an internal regulatory policy resource and interfacing with internal and external stakeholders to provide updates and respond to project-related questions
- Monitoring changes to drug and device regulations with relevance to Unlearn
- Implementing a Quality Management System and providing leadership on quality policies and practices
- Overseeing all quality activities and ensuring they are governed through key performance metrics and a quality review system.
- Work closely with internal departments to assure compliance with quality systems and related regulations.
You are an experienced pharmaceutical or biotechnology regulatory affairs specialist that wants to take on a company and industry defining role. You have deep knowledge of the regulatory process that takes a drug from an idea to a marketed product, and want to drive the adoption of innovative approaches to clinical trials that can accelerate that process.
You'll likely have:
- Bachelor's degree in a scientific discipline. Advanced degree is a plus, e.g. MBA, MHA, MPH, MS, PhD, JD
- 4+ years experience leading interactions with FDA and similar global regulatory agencies (including meeting requests, intermediate meetings, formal regulatory filings)
- Certification in Quality Assurance or Regulatory Affairs preferred (ISO 13485, ISO 127001, ASQ-CQA)
- Working knowledge and understanding of Medical Device regulations and standards such as 21CFR 820, 21CFR Part 11, ISO 13485 and Risk Management (ISO 14971)
- Knowledge in how clinical data and real-world evidence are used to support regulatory filings for new drugs
- Experience with regulatory interactions around quantitative drug development tools or statistical analysis plans
- In-depth knowledge of applicable clinical research regulatory requirements such as laws, regulations, and guidances related to drug and device development, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Experience coordinating with internal teams (e.g., scientific, executive), customers, regulatory agencies, and external consultants
- Health policy expertise and established relationships strongly preferred
- Understanding of variation in the regulatory landscape across therapeutic areas (neurosciences, rare diseases, oncology, etc)
- Possess a startup mindset and enjoy a fast-paced environment
This position has the opportunity to be remote or work out of our downtown San Francisco office.
Compensation & benefits
Unlearn offers compensation commensurate with experience as well as a competitive benefits package, including:
- Generous equity participation.
- Unlimited PTO plus company holidays.
- Annual company-wide shutdown between Christmas and New Years holidays.
- Professional development budget to attend conferences or other events.
- 401k plan with generous matching.
- Company-subsidized medical, dental, & vision insurance plans.
- Commuter benefits plan.
- Paid Parental Leave
Unlearn is not currently offering visa sponsorships for any position. Please only apply if authorized to work in the U.S.
Before you apply, please check if any restrictions apply in terms of time zone or country.
This job has a geo-restriction in place: USA Only.
Please mention that you come from Remotive when applying for this job.
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