Senior Director, Global Regulatory Affairs Strategist at Flatiron Health (Greater NYC Area, NY or Remote)

| Greater NYC Area | Remote
Sorry, this job was removed at 9:02 a.m. (EST) on Tuesday, November 30, 2021
Find out who's hiring in Greater NYC Area.
See all Legal jobs in Greater NYC Area
Apply Now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

We're looking for a Senior Director, Global Regulatory Affairs Strategist 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.

Reporting to the VP of Regulatory Affairs, this role is a unique opportunity to influence the development of Flatiron’s Regulatory Affairs function and lead regulatory strategy for real-world evidence by working with sponsors and Health Authorities globally (e.g. FDA, EMA, national EU Health Authorities, PMDA).   

In this role, you will lead global regulatory affairs strategy for Flatiron Health in collaboration with sponsors through drug development project work and in collaboration with Health Authorities through research initiative work. A deep understanding of clinical oncology drug development strategy and operations is important for this role.

Because Flatiron's work is in a rapidly evolving space at the forefront of regulatory innovation, it is important that you have had experience in direct interactions with the FDA and other health authorities in a strategic oncology regulatory capacity. This includes all aspects of the drug development process, from pre-IND or equivalent, development phase, marketing authorization, product labeling and promotion, post approval, advanced diagnostics and pertinent other (e.g. Breakthrough or orphan drug) applications or submissions, excluding chemistry, manufacturing and controls expertise. 

What You'll Do 

You will guide the regulatory strategy for Flatiron’s research oncology initiatives and sponsor work. In addition, you will:  

  • Develop, implement, and manage the global regulatory strategy consistent with Flatiron’s overall company objectives, strategy, both as a business and in partnership with sponsors’ specific drug product/asset needs 
  • Support business development due diligence activities as required 
  • Ensure Flatiron’s adherence to all local and national regulatory reporting obligations and requirements in all relevant jurisdictions (including pharmacovigilance obligations), and support the processes and audit functions or interfaces to properly implement these responsibilities in partnership with Flatiron’s Quality organization 
  • You will work directly with the FDA and consortia on clinical research projects 

While it is not anticipated that Flatiron Health will take primary responsibility for health authority submissions, critical components of regulatory submissions are expected deliverables from sponsors who work with us, and as such regulatory project management and writing expertise amongst the regulatory affairs team is required.  

Who You Are 

You're a regulatory science expert and leader with at least 10 years of experience in regulatory oncology drug development within the biopharmaceutical industry. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day, with a forward-looking mentality as it relates to the development of an innovative regulatory strategy. 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 an advanced degree (e.g. PharmD, PhD, MD, DVM, MBA), however an extensively broad and deep set of experiences within the discipline of regulatory sciences within biopharma may be sufficient with a BA or BS or equivalent 
  • You have cross-functional team experience and product team leadership experience is a plus 
  • You have solid knowledge of IND/CTA through BLA/NDA/MAA or equivalent submission requirements, preferably with both the US FDA and EMA; the US FDA is  a minimum 
  • Fluent knowledge of all stages of pharmaceutical drug development and compliance and documentation  
  • You are knowledgeable in ICH, FDA and EMA statutes, guidelines, guidances, initiatives, and other regulations governing regulatory compliance and reporting, including safety reporting and processing within the clinical investigation and post marketing settings
  • You have strong organizational, matrixed leadership, teamwork, and interpersonal skills, as well as a passion for developing teams
  • You have experience managing and developing a team  
  • You have outstanding communication skills (written and verbal, both formal and informal) 
  • You have the ability to manage multiple projects simultaneously in a fast paced environment 
  • You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams 

If this sounds like you, you'll fit right in at Flatiron.  

Extra Credit: 

You have had direct strategic regulatory oversight of at least one program through pivotal development, marketing authorization application preparation, regulatory review, label negotiations and approval.  

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. 

At Flatiron, we strive to build and maintain an environment where employees from all backgrounds are valued, respected and have the opportunity to succeed. 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.

Read Full Job Description
Apply Now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Technology we use

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


Our headquarters at One Soho in NYC 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.


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.


Software Engineer

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.


Medical Writer

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

We are committed to providing our employees with the resources they need both in and outside of work to enable them to focus their working hours on improving cancer care and accelerating cancer research, and their non-working hours on everything else life has to offer.

We offer a full range of benefits to support our employees and their families. These benefits include health and wellness, family planning, financial planning and time away. Additionally, we offer a variety of day-to-day perks and benefits that foster an inclusive culture, nurture our community and invest in each team member’s professional development.

Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Documented equal pay policy
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Mental Health Benefits
Retirement & Stock Options Benefits
401(K) Matching
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
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
Some Meals Provided
Happy Hours
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Promote from within
Mentorship program

More Jobs at Flatiron Health

Apply Now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.
Save jobView Flatiron Health's full profileSee more Flatiron Health jobs