Director, Regulatory CMC

Location
Cambridge, MA, United States
Posted
Nov 14, 2018
Ref
1321962
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative Regulatory CMC team by contributing to the overall success of our novel gene therapy approach. bluebird bio is looking for a Director or Senior Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory filings for gene therapy projects both in the US and internationally 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 CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, strategic partners, 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
  • Lead CMC Regulatory activities and timelines
  • Manage and implement planning, preparation and submission of high-quality CMC-related applications in the US, EU and Japan
  • Manage, develop, and build a team of experienced professionals in a very collaborative environment
  • 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
  • Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support 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
  • Lead 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:
  • Masters degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree, such as a PhD is desirable
  • Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in CMC-focused Regulatory Affairs for biologics, direct interactions with regulatory health authorities and BLA/MAA filings, and ideally in an area related to cell or gene therapy
  • Experience in post-approval dossier life cycle management and direct interactions supporting health authority GMP inspections desirable
  • Excellent written and communication skills, strong technical knowledge, including CMC-regulatory writing
  • Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.
  • Detail oriented; science-based reasoning skills
  • Ability to execute and follow-through to completion and documentation
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated and solution oriented
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
  • Ready to embrace the culture of an evolving environment and the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself