Head of Regulatory Affairs at Flatiron Health
We're looking for a Head of Regulatory Affairs 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 Chief Medical Officer, this role is a unique opportunity to lead and build Flatiron’s Regulatory Affairs function.
In this role, you will lead all aspects of global regulatory affairs for Flatiron Health and in collaboration with our life science partners, including organizational and managerial oversight of all regulatory functions, such as oncology strategy, policy and operations, including oversight and compliance with pharmacovigilance obligations. Thus, the development, optimization, and oversight of all functional processes, training, and SOPs within regulatory and pharmacovigilance for Flatiron will also be required.
Because Flatiron's work is in a rapidly evolving space at the forefront of regulatory innovation, it is important that you have had extensive experience in direct interactions with the US Food and Drug Administration 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
Reporting to the Chief Medical Officer, you will establish an integrated regulatory affairs function within Flatiron Health, guide the regulatory strategy for Flatiron’s research oncology initiatives, and build and manage the regulatory and pharmacovigilance operational infrastructure to support all research and development regulatory needs. In addition, you will also:
- Lead Flatiron’s Regulatory team and establish a robust regulatory science organization, with processes and procedures on behalf of all regulatory business needs within Flatiron
- 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, oversight, quality assurance and audit functions or interfaces to properly manage these responsibilities, in partnership with Flatiron’s Quality organization
- Support business development due diligence activities as required
- Develop, implement, and manage the team’s global regulatory strategy consistent with Flation’s overall strategy, both as a business and in partnership with our clients’ specific asset/product needs
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 our clients, and as such regulatory project management and writing expertise amongst the regulatory affairs team is a must.
Who You Are
You're a regulatory science expert and leader with at least 15 years of experience in regulatory drug development within the biopharmaceutical industry, preferably in oncology. 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 had direct managerial experience for at least 6 years
- You have enterprise level experience (i.e. experience not confined to product teams) preferably with direct functional accountabilities, however cross-functional experiences may suffice
- You have solid knowledge of IND through BLA/NDA or equivalent submission requirements, preferably with both with at least the USFDA and EMA; the USFDA 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, and safety reporting and processing within the environment of clinical investigation and post marketing; preferably with direct experience with safety reporting to development partners (e.g., safety data exchange agreements)
- You have strong organizational, management, matrixed leadership, teamwork, and interpersonal skills, as well as a passion for leading and developing teams
- 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.
- 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.