Senior Manager, Regulatory Strategy

Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Senior Manager of Regulatory Strategy to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?
What You'll Do
In this role, you will primarily work with the Regulatory Strategy & Operations team and the Clinical Research Business Unit (CRBU) in support of data products, software, and services intended to disrupt traditional approaches to clinical research. Reporting to the Director of Regulatory Strategy, you'll be responsible for developing and implementing Flatiron's regulatory strategy for generating prospective real-world evidence (RWE) from prospective real-world studies (PrwS).
This role will be responsible for:

• Enabling successful regulatory submissions and evidence generation strategies for our life science partners by effectively leveraging prospective RWE in submissions for potential regulatory decisions, initially focused in the post-approval setting. While the primary focus will be in the US with FDA, the focus may expand internationally over time (e.g., European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PDMA]).
• Lead and support interactions with life science clients' drug development teams, medical affairs teams, relevant external policy groups, and health authorities as appropriate. While this position will not directly handle IND or NDA/BLA submissions (i.e., as Flatiron is not the sponsor of the drug), successful candidates will leverage their regulatory affairs expertise to assist Flatiron Health and our partners navigate the regulatory submission life-cycle.
• Develop, implement, and oversee execution of the regulatory strategy roadmap and initiatives
• Interpret relevant regulatory guidances to support Flatiron Health's product and process development as well as proactively develop Flatiron perspectives and supporting documentation
• Collaborate with internal cross-functional teams, including clinicians, clinical operations, epidemiologists, biostatisticians, software engineers, quality management, product, legal, and regulatory policy teams
• Foster a quality culture focused on meeting high quality, ethical and compliance standards
• Have a working knowledge of Good Clinical Practices and Pharmacovigilance requirements

Who You Are
You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you're a regulatory professional with:

• Minimum education & experience requirements:
• Degree in biological science or related discipline
• B.S., with minimum of 7 years of relevant regulatory affairs & drug development experience
• M.S., with minimum of 6 years of relevant regulatory affairs & drug development experience
• MD/PhD/PharmD, with minimum of 5 years relevant regulatory affairs & drug development experience
• Direct experience within a highly regulated environment (e.g. life science company, contract research organization (CRO), health authority, etc.) in healthcare and/or research
• Direct experience with filing and approval of a new drug application (NDA) or biologics license application (BLA) or comparable international submissions
• Direct experience in with post-marketing approval marketing applications, labeling and promotional material reviews
• Experience writing and reviewing documents suited for a regulatory audience (e.g., meeting requests and briefing 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

Extra credit

• 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, statistical analysis plans, 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 drug development experience

Where you'll work
In this hybrid role, you'll have a defined work location that includes work from home and 2-3 office days set by you and your team with the option of being Flex or Office. For more information on our approach to hybrid work as well as our work type options, please visit the how we work website.
Life at Flatiron
At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

• Work/life autonomy via flexible work hours and flexible paid time off
• Comprehensive compensation package
• 401(k) contribution to help you reach your retirement planning goals
• Financial health resources including 1:1 financial advice
• Mental well-being tools and services
• Parental benefits and policies including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services
• Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace.

Job Compensation Range
Salary Range: $152,000.00 - $228,000.00

Preferred Primary Location: NYC Headquarters
The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.