Manager, Regulatory Strategy [Regulatory Affairs]
We're looking for Regulatory Strategy and Regulatory Affairs experts to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team and why Flatiron Health is the right next step in your career.
What You'll Do
In this role, you'll 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]). In addition, you'll also:
- 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 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
- Support peer to peer interaction with life science partners’ regulatory teams
- Foster a quality culture focused on meeting high quality, ethical and compliance standards
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).
Who You Are
You're someone with hands on experience with FDA submissions with:
- Manager Level: At least 6 years of direct regulatory affairs experience
- Senior Manager Level: At least 8 years of direct regulatory affairs experience
You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You have direct experience within a highly regulated environment (e.g. life science company, contract research organization (CRO), etc.) in healthcare and/or research
- You have direct experience with post-market approval applications, labeling and promotional material reviews
- You have direct experience with filing and approval of a new drug application (NDA) or biologics license application (BLA) or comparable international submissions
- You have 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
- You have the ability to flexibly apply regulatory affairs experience and subject-matter expertise to novel evidence sources
- You have the ability to effectively work cross-functionally and manage multiple projects simultaneously
If this sounds like you, you'll fit right in at Flatiron.
- You have direct experience with complex regulatory interactions (e.g., clinical holds, expedited programs for serious conditions etc.)
- You have experience with real-world evidence or novel data sources
- You are familiar with oncology and the regulatory issues that are of particular interest in oncology
- You have an understanding of the global regulatory landscape (e.g., EMA regulations etc.)
- You have experience with designing protocols and/or case report forms
- You have experience with health outcomes and economic research
- You have a Bachelor’s degree with preference for advanced degrees with a science-related discipline
- You have scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
- You have clinical experience (e.g., RN, CRN etc.)
Why You Should Join Our Team
A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.
You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer:
- Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
- Career coaching opportunities
- Hackathons for all employees (not just our engineers!)
- Professional development benefit for attending conferences, industry events and external courses
- Work/life autonomy via flexible work hours and flexible paid time off
- Generous parental leave (16 weeks for either parent)
- Back-up child care
- Flatiron-sponsored fitness classes
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.