ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
The Regulatory flock is all about making a profound impact on people living with rare diseases through teamwork, strategic conviction, operational focus, and individual accountability to the mission of establishing gene therapy as a meaningful option for patients. We seek an experienced Director, Regulatory Strategy who will be responsible for the regulatory strategy and post-approval lifecycle management for at least one of bluebird bio’s orphan gene therapy programs. Come work with a kickass group of birds that are committed to be the change that we want to see in the world….and have some fun together along the way!
HOW YOU’LL FLY
You’ll help to bring patients and their families more bluebird days by:
- Providing regulatory strategy for post-approval life cycle management of a rare disease gene therapy product, as well as development program with ongoing clinical studies
- Managing preparation and submission of high-quality regulatory dossiers in the US (and the EU) according to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science
- Managing transparent and proactive regulatory agencies interactions.
- Collaborating with regulatory-CMC function as needed
- Collaborating with pharmacovigilance to ensure timely submission of SUSARs, and quarterly PAERs.
- Work cross functionally to ensure timely execution of submission activities related to fulfilling post marketing commitments, and responses to FDA information requests.
- Participate in the cross-functional review and authoring sections as appliable, for the key clinical documents including investigator’s brochures, DSUR, protocols, clinical study reports
- Managing Ex-US regulatory activities related to continued conduct of clinical trials.
- Driving adherence to regulatory guidelines/regulations for study conduct and post-approval lifecycle management of gene therapy products
- Maintaining knowledge of global competitive landscape, regulatory environment, regulations, and guidelines and participate in regulatory intelligence activities
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- BA/BS degree in life sciences, MS/PhD preferred and 10+ years of pharmaceutical product development, of which at least 8 years in regulatory strategy, preferably in biologics for rare diseases
- Experience as primary regulatory lead for post-approval and IND/CTA submissions
- Well-versed in regulatory strategy, and regulatory science writing
- Results-driven with an enthusiastic attitude, and the ability to influence outcomes
- Exceptionally strong team leader and team player with excellent communication skills, coaching, project management, problem-solving, risk management, and presentation skills
- Ability to work effectively in a collaborative team environment
- Understanding of advanced therapy products development
- Knowledgeable in ICH and FDA guidelines
Compensation & Benefits
We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $187,000 - $252,179. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as paid holidays, bluebird days, and a holiday shutdown in December.
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.