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 1100+ 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 and cellular 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 and our Oncology Franchise. Patients are waiting and we know we are making a difference every day when we show-up to the nest!
As Regulatory Science team member, you will work with the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to collaborate. We see regulators as partners. Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.
We seek an experienced Director who will be responsible for overseeing programs in our Oncology franchise to develop registration strategies for our innovative cellular therapy programs from pre- IND to Phase 3 and registration. You will be responsible for the preparation, submission and approval of INDs, CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities. In addition, you will be responsible for upcoming marketing applications, leading teams through submission, approval and post approval. You must have the ability and drive to manage, build and grow a team of regulatory professionals to manage our growing Oncology portfolio."
HOW YOU’LL FLY
As a Regulatory Science bird reporting to our Senior Director, Regulatory Strategy, you'll help to bring more patients their bluebird days by:
- Design creative regulatory strategy for the global development for several products in the Oncology portfolio
- Manage preparation and submission of high-quality dossiers including development of timelines. This will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
- Lead transparent and proactive interactions with regulatory agencies globally.
- Collaborate with regulatory-CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
- Drive adherence to regulatory guidelines for development of cellular therapy products.
- Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you possess:
- BA/BS degree in life sciences, MS/PhD preferred
- At least 6-8 years of pharmaceutical product development
- Well-versed in regulatory strategy and regulatory science writing
- Experience leading Agency meetings and IND and CTA activities
- Knowledgeable in ICH, FDA and EMA guidelines
- Big plusses: Experience in oncology, gene or cell therapy, BLA/MAA experience, managerial experience
- Understanding of advanced therapy products development
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications skills and ability to influence across multiple functions
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.