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Director – Regulatory Affairs Strategy
Posted on 10/19/2022
INACTIVE
Locations
San Francisco, CA, USA • Remote • New York, NY, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Marketing
Communications
Requirements
  • 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 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
  • 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
Responsibilities
  • 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
Desired Qualifications
  • You have cross-functional team experience, product team leadership, and management experience is a plus
Flatiron Health

1,001-5,000 employees

Improving healthcare by learning from the experience of cancer patients
Company Overview
Flatiron seeks to identify and solve problems that drive work that moves the needle for customers and patients. In short, they seek to learn and improve cancer research from each patient.
Benefits
  • Work/life autonomy via flexible work hours and flexible paid time off
  • Generous parental leave (16 weeks for either parent)
  • Transition back to work program following parental leave
  • Child and caregiver travel benefits for new parents
  • Backup child care
  • Weekly meditation sessions
  • Flatiron-sponsored fitness classes
  • Weekly massages and manicures available onsite (employee funded)
Company Core Values
  • Solve problems that matter
  • Be kind
  • Start with why
  • Think yes before no
  • Focus on your customer
  • Seek feedback at 30%
  • Be willing to sit on the floor
  • Know when to startup and when to scale
  • Learn, teach and grow
  • Do the right thing