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Associate Director, Reg-CMC 10/16/2019

Bluebird Bio Inc. Cambridge, MA

Location
Cambridge, MA
AJE Ref #
585072210
Job Classification
Full Time
Job Type
Regular
Company Ref #
1904741
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

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Regulatory CMC, Associate Director

bluebird bio is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory filings for gene therapy projects (CAR T cell therapy) both in the US and internationally for our growing oncology 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 CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, and global health authorities.

About the Role:

* Manage CMC Regulatory activities and timelines

* Manage and implement planning, preparation and submission of high-quality CMC related applications in the US and EU

* Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures and pediatric investigation plans, and MAAs or BLAs are complete, well written, and meet all relevant requirements

* Participate in 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 and work very closely with Pharmaceutical Science, 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



About You:

* Minimum BA/BS degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree preferred

* Minimum 5 years of relevant biopharmaceutical industry experience, with at least 4 years experience in CMC-focused Regulatory Affairs preferably for biologics, ideally with experience of regulatory interactions and BLA or MAA filings, and ideally in an area related to cell or gene therapy

* Excellent communication skills, including CMC regulatory writing; an ability to pay attention to and communicate details; ability to influence across multiple functions

* Ability to work both independently and collaboratively in a team structure and thrive in a fast-paced, multi-task environment; demonstrated ability to work well under pressure

* Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines

* Familiarity with CMC operations, including Quality and Manufacturing technical strategy

* Ready to embrace the culture of a start-up environment and the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself







.

b yourself.
bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, age, gender (including pregnancy, childbirth, or related medical conditions), sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or other applicable legally protected characteristics.