Manager / Senior Manager, Regulatory Affairs [FDA strategy focused]

| Greater NYC Area

[Please note that this is an office based position at Flatiron's office in New York, NY]

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).

Responsibilities (involvement may vary based on level)

  • 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

Requirements

  • Hands on experience with FDA submissions as follows:
    - Manager Level: At least 6 years of direct regulatory affairs experience
    - Senior Manager Level: 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

Bonus Points:

  • 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.)
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Technology we use

  • Engineering
    • .NETLanguages
    • C#Languages
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • jQueryLibraries
    • ReactLibraries
    • AngularJSFrameworks
    • ASP.NETFrameworks
    • Node.jsFrameworks
    • Microsoft SQL ServerDatabases
    • PostgreSQLDatabases

Location

Our office at One Soho is easily accessible and modern, and has all the amenities our employees need to be comfortable, productive and collaborative.

An Insider's view of Flatiron Health

What kinds of technical challenges do you and your team face?

An engineer and oncologist work together over several weeks to build an algorithm from a naive prototype to a highly specialized and flexible rule set that can accurately represent the lines of therapy for 95% of patients within a specific disease subset.

Abhishek

Software Engineer

How does the company support your career growth?

As engineering manager, I am invested in the professional development of the people I work with. I train team members by pulling them out of their comfort zones to the uncomfortable territory. At Flatiron, it is one of our values - greatness and comfort rarely co-exist.

Kevin

Software Engineer

What is your vision for the company?

At Flatiron, we believe that learning from the experience of every cancer patient is an imperative — it is the key to accelerating research and continuing to improve the quality of care. Our mission is to serve cancer patients and our customers by dramatically improving treatment and accelerating research.

Zach Weinberg

Co-Founder, President and COO

What's the biggest problem your team is solving?

Instead of studying the cells, I now have the opportunity to write about the patients. I can tell their stories through the research lens and enable them to advance clinical cancer research through their experiences. I certainly never lose sight of the human behind the cell anymore.

Rana

Medical Writer

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

Flatiron has a holistic approach to employee experience. We promote a culture with wellness at the forefront.

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Unconscious bias training
Diversity manifesto
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Stocked Kitchen
Happy Hours
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
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