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.
bluebird bio is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the global development and submission of regulatory dossiers for gene therapy projects for our severe genetic diseases franchise. In this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with our in-house Pharmaceutical Sciences, Quality and Manufacturing teams, contract manufacturing organizations, external experts and global health authorities.
About the role:
- Provide regulatory CMC strategic leadership to support development of multiple innovative gene therapy products for the treatment of severe genetic diseases
- Manage and implement planning, preparation and submission of high-quality CMC‑related applications in the US, EU and other regions with a focus on the EU/EMEA region
- Ensure that CMC-related applications, including INDs/CTAs, MAAs and BLAs are complete, well written, and meet all relevant requirements
- Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections
- Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
- Partner closely with Pharmaceutical Sciences, Quality, Nonclinical, Clinical and Regulatory Project Leads to ensure achievement of submission deadlines and obtain timely approvals of bluebird bio CMC‑related applications
- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to bluebird bio in-house CMC teams and Project/Product teams
- Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields; PhD degree desirable
- At least 7 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused Regulatory Affairs preferably for biologics, and ideally with experience in MAA or BLA filings for cell or gene therapy, late stage clinical development, and/or post-approval regulatory dossier life-cycle management.
- Excellent written and oral communication
- Strong knowledge of current Good Manufacturing Practices (GMP), experience with on-site health authority inspections desirable
- Familiarity with CMC operations, including Quality and Manufacturing technical strategy
- Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.
- Superb organizational and communication skills, both written and oral skills, and “do-what-it-takes” attitude
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment
To all recruitment partners: bluebird bio does not accept resumes. Please do not forward resumes to our jobs alias, our birds or any other organization location. bluebird bio is not responsible for any fees related to unsolicited resumes.
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.