Director / Senior Director, Global Regulatory Affairs Strategist
- New York, NY
We're looking for a Director / 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 Head 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
Reporting to the Head of Regulatory Affairs, 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
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 8 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.
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.
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