Director, Regulatory Affairs Strategy

NYC or SF or Remote

Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.

We’re looking for a Director, Regulatory Affairs Strategy to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Are you ready to be the next changemaker in cancer care?

What You'll Do

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

Because Flatiron works 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 to marketing authorization, product labeling and promotion, post-approval life-cycle management, advanced diagnostics and pertinent other regulatory designations (e.g. Breakthrough or orphan drug) or submissions; chemistry, manufacturing and controls expertise is less relevant to the regulatory position.

In this role, you will lead regulatory affairs strategy for Flatiron Health in collaboration with sponsors through drug development project work and mentoring a team of regulatory affairs strategists and operations. You will work cross-functionally with clinicians, statisticians, data scientists, commercial, project management and software engineers.

In addition, you will also:

• 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
• 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 and Compliance organization
• You will work with Sponsors of medical products

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 among the regulatory affairs team is required.

Who You Are

You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you're a regulatory science expert with at least 5 years of experience in regulatory oncology drug development. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day, with a forward-looking mindset as it relates to the development of an innovative regulatory strategy.

• 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, product team leadership, and management 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, 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

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.
• You have worked experience with real-world data.
• You have worked at a real-world data company, pharma, or CRO as a regulatory affairs strategist.

Life at Flatiron

At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

• Work/life autonomy via flexible work hours and flexible paid time off
• Comprehensive compensation package
• 401(k) contribution to help you reach your retirement planning goals
• Financial health resources including 1:1 financial advice
• Mental well-being tools and services
• Parental benefits and policies including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services
• Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace.

Job Compensation Range

Salary Range: $181,600.00 - $272,400.00

Preferred Primary Location: NYC Headquarters

The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.

https://flatiron.com/careers/open-positions/4636084