Director, Regulatory Affairs

Employer
Glympse Bio
Location
02139, Cambridge
Posted
Jan 07, 2019
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

Imagine a future where a simple urine test can detect deadly diseases before they get out of control. A future when diseases can be intercepted and people don’t become patients. At Glympse Bio, we are working to turn this vision into a reality. Take a glimpse into that future, where we are taking a glimpse inside the body. 

Job Summary

Glympse Bio is looking for an experienced and highly motivated Director of Regulatory Affairs to contribute towards the development of activity-based sensors in nonalcoholic steatohepatitis (NASH), liver fibrosis, and liver cancer. This role will be responsible for leading combination product regulatory activities, including drug and device development, protocol reviews, clinical trials, and health authority correspondence and submissions. The candidate will have an opportunity work with a world-class R&D team to develop cutting-edge products to improve patient care.

Responsibilities and Duties

  • Provide regulatory interpretation, position and strategy for drug – device combination products, including development of constituent parts and clinical trials.
  • Support drug and device development activities from a regulatory standpoint during early phase, development, clinical trials, submissions and post market requirements
  • Support development of design control documentation and quality systems for combination products
  • Support combination regulatory submissions, including collecting Health Authority (HA) feedback, IDE, CTA, BLA, NDA and PMA applications and MAA filings.
  • Conduct HA correspondence on combination product topics and participate in HA meetings on this topic

Qualifications and Skills

  • BS/MS in life science related field
  • 10+ years of experience in a pharma/biotech/medical device regulatory affairs setting; RAC certification
  • Expertise with combination products, including clinical trials, and design controls for device development; experience interacting with, managing and coordinating a wide variety of consultant experts
  • Experience preparing combination product regulatory submissions to global health agencies
  • Experience interacting with health authorities for combination products
  • Human factors experience a plus
  • Excellent oral communication and technical writing skills