Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2).
Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies.
Proactively identify and communicate potential risks and define mitigation strategies.
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Their work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.