Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Associate Director, Regulatory Science who will be responsible for managing an exciting program from Phase 1 through to Phase 3 in our Severe Genetic Disease franchise. Position will require managing interactions with global health authorities, working closely with the clinical development teams to design Phase 3 protocols, managing submissions of investigational new drug application (IND) amendments, clinical trial applications (CTAs), pediatric investigation plans and orphan drug designations.
About the position:
- Collaborate with regulatory and cross-functional colleagues on the design of clinical development programs and the preparation and submission of regulatory filings; 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
- Lead negotiations with regulatory agencies to design clinical trial protocols 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
- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends
- Advanced degree in biochemistry, chemistry, biology or related pharmaceutical fields including bio-chemical engineering
- Minimum 5-8 years of regulatory experience in a biotech/pharma company
- Experience with Agency meetings, especially FDA
- 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
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.