Sr. Manager, Regulatory Strategy, Sickle Cell Disease

Cambridge, MA, United States
Sep 25, 2018
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Regulatory Science professional who will be responsible for managing submissions of investigational new drug application (IND) amendments, clinical trial applications (CTAs), pediatric investigation plans and orphan drug designations, as well as for supporting major marketing applications in the US and Europe.

About the position:
  • Collaborate with regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US and Europe; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science
  • Prepare submissions plans and manage timelines for regulatory submissions
  • Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, pediatric investigation plans
  • Participate in negotiations with regulatory agencies to resolve issues, and prepare and submit responses to questions
  • Act as primary regulatory liaison with Clinical team and external CROs to manage the initiation and conduct of clinical trials
  • Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines, and internal style guidelines and requirements including SOPs
  • Manage regulatory documentation and submission logs
  • Assist team during regulatory agencies inspections
  • Participate in regulatory intelligence activities; monitor regulatory guidelines and trends

About you:
  • Advanced degree in biochemistry, chemistry, biology or related pharmaceutical fields including bio-chemical engineering
  • Minimum 8+ years of regulatory experience in a biotech/pharma company, preferably in biologics
  • Experience with regulatory writing
  • Experience in orphan drugs preferred
  • Understanding of the development of advanced therapy/innovative biologics products a plus
  • Knowledgeable in ICH, FDA and EMA guidelines
  • Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred
  • 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, detail oriented and good problem solving ability
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent communication skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself