Description
About The Nest
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 500+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
About The Flock
bluebird bio's Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients' lives. We have a lot of work to do across our Severe Genetic Diseases Franchise. Patients are waiting and we know we are making a difference every day when we show-up to the nest!
How You'll Fly
As a Regulatory Strategy bird reporting to our Senior Director, Regulatory Science, you'll help to bring more patients their bluebird days by:
- Driving US regulatory strategy for betibeglogene autotemcel for the treatment of transfusion-dependent beta-thalassemia
- Supporting review and approval of major marketing authorization applications
- Collaborating with cross-functional team to prepare high quality submissions per agreed-to timelines
- Supporting the FDA review of the BLA for betibeglogene autotemcel for the treatment of beta-thalassemia by leading the efficacy BLA and Advisory Committee Teams
- Collaborating with cross-functional team to prepare high quality strategic submissions
- Driving US strategy and life cycle management of betibeglogene autotemcel after BLA approval
What You'll Bring
You're the bird we're looking for if you have:
- BA/BS degree in life sciences, MS/PharmD/PhD preferred
- At least 6-8 years of pharmaceutical product development
- Well-versed in regulatory strategy and regulatory science writing
- Knowledgeable in ICH and FDA guidelines
- Independently motivated, detail oriented, excellent communications and organization skills with ability to influence across multiple functions and multi-task in a fast-paced environment
- Big plus: Experience in gene or cell therapy, BLA/MAA experience, managerial experience
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
