Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Director who will be responsible for overseeing programs in our Severe Genetic Disease franchise to developing registration strategies for our innovative gene therapy programs from pre IND to Phase 3 and registration. You will be responsible for the preparation, submission and approval of CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities, as well contribute to building a team of regulatory professionals to manage our growing Severe Genetic Disease portfolio.
About the role:
- Design creative regulatory strategy for the global development for several products in the Severe Genetic Disease portfolio
- Manage preparation and submission of high-quality dossiers including development of timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
- Lead transparent and proactive interactions with regulatory agencies globally.
- Collaborate with regulatory-CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
- Drive adherence to regulatory guidelines for development of gene therapy products.
- Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends.
- Review all medical affairs/commercial materials to ensure compliance with regulations
- BA/BS degree in life sciences, MS/PhD preferred
- At least 8-10 years of pharmaceutical product development
- Well-versed in regulatory strategy and regulatory science writing
- Experience leading Agency meetings and IND and CTA activities
- Knowledgeable in ICH, FDA and EMA guidelines
- Big plusses: Experience in rare diseases, gene or cell therapy, BLA/MAA experience, managerial experience
- Understanding of advanced therapy products development
- 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
- Excellent people leadership skills
- 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.