We seek an experienced global regulatory lead, who will be responsible for developing a registration strategy for our innovative gene therapy sickle cell disease (SCD) program. 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 hematopoietic stem cell product portfolio.
About the role:
- Design creative regulatory strategy for the global development of the sickle cell disease product LentiGlobin BB305 Drug Product.
- 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 for the sickle cell disease program 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 5-10 years of pharmaceutical product development
- Well-versed in regulatory strategy and regulatory science writing
- Experience as primary regulatory lead for IND and CTA activities
- Knowledgeable in ICH, FDA and EMA guidelines
- Big plusses: Experience in rare diseases, gene or cell therapy, BLA/MAA experience
- Understanding of advanced therapy products development
- Ability to work independently and thrive in a fast-paced environment
- Attention to detail
- Excellent people leadership skills
- 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.
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