Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Flatiron Health is accelerating research with the most advanced real-world evidence (RWE) platform in oncology. We build RWE data sets with high quality, accuracy, recency, and scale, allowing our partners to use RWE to answer critical questions. Flatiron Health has active partnerships with the top 15 life science companies, top-tier academic medical centers, and the Food and Drug Administration (FDA).
To support our RWE platform, Flatiron Health is seeking Regulatory Affairs experts to join our team. This role will be responsible for enabling successful regulatory submissions for our life science partners by effectively leveraging RWE in evidence packages for the approval of drugs, biologics, and/or medical devices. While the primary focus will be FDA approvals, the focus will expand internationally over time (e.g., European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PDMA]).
This role will support peer to peer interaction with life science partners’ regulatory teams. While this position will not directly handle submissions (i.e., Flatiron is not the sponsor), successful candidates will leverage their deep regulatory affairs expertise to assist Flatiron Health and our partners navigate the regulatory submission life-cycle from discovery (e.g. using RWE to define drugs targets) to post-marketing activities (e.g. using RWE for new indications).
Define, implement, and enhance Flatiron’s regulatory affairs strategy, operations, and best practices to support formal and informal regulatory meetings
Implement creative solutions to enable successful inclusion of RWE in life science partners’ regulatory submissions
Act as the subject matter expert to coordinate responses to information requests from regulators
Develop, implement and oversee execution of the the regulatory affairs roadmap
Keep abreast of pertinent regulations and guidance relevant to oncology products and the supporting regulatory best practices
Collaborate with internal cross-functional teams, including Research Oncology, Quantitative Sciences, Engineering, Quality, Product, Legal, Regulatory Policy, and Operations
Foster a quality culture focused on meeting high quality, ethical and compliance standards
Hands on experience with FDA submissions as follows: - At least 8 years of direct regulatory affairs experience
Direct experience within a highly regulated environment (e.g. life science company, contract research organization (CRO), etc.) in healthcare and/or research
Direct experience in with post-market approval applications, labeling and promotional material reviews
Direct experience with filing and approval of a new drug application (NDA) or biologics license application (BLA) or comparable international submissions
Experience writing and reviewing documents suited for a regulatory audience (e.g., common technical documents, clinical study reports, etc.) with the ability to translate internal team documents into formal documentation ready for regulator review
Ability to flexibly apply regulatory affairs experience and subject-matter expertise to novel evidence sources
Ability to effectively work cross-functionally and manage multiple projects simultaneously
Direct experience with complex regulatory interactions (e.g., clinical holds, expedited programs for serious conditions etc.)
Experience with real-world evidence or novel data sources
Familiarity with oncology and the regulatory issues that are of particular interest in oncology
An understanding of the global regulatory landscape (e.g., EMA regulations etc.)
Experience with designing protocols and/or case report forms
Experience with health outcomes and economic research
Bachelor’s degree with preference for advanced degrees with a science-related discipline
Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
Clinical experience (e.g., RN, CRN etc.)
Internal Number: P0001270
About Flatiron Health
Flatiron Health’s mission is to improve lives by learning from the experience of every cancer patient. Accelerating the fight against cancer requires the entire industry to work together. Our products connect community oncologists, academics, hospitals, life science researchers and regulators on a shared technology platform.