Director, Regulatory CMC, Severe Genetic Disease
Bluebird Bio, Cambridge, MA, USA
integrated product platforms with broad therapeutic potential
bluebird bio is looking for a Director in Regulatory CMC for biologics who will be responsible for the strategic development and submission of regulatory filings for one of the lead gene therapy projects at bluebird bio both in the US and internationally. 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 and Quality teams, contract manufacturing organizations, external experts and global health authorities.
About the role:
- Responsible for all CMC regulatory activities for late stage gene therapy project
- Manage and implement planning, preparation and submission of high-quality CMC‑related applications in the US, EU and Australasia
- Ensure that CMC-related applications, including INDs/CTAs, MAA and BLA 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 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 including chemical engineering required; PhD degree desirable
- 5-10 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 BLA or MAA filings, 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
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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