Executing regulatory strategies for therapeutic programs, the full-time Manager, Regulatory Affairs will manage high-quality regulatory submissions and provide guidance to cross-functional teams, with the flexibility to work either onsite in New York City or remotely. Key responsibilities Participate in the development and implementation of regulatory strategies from candidate selection through post-marketing support Coordinate the authoring, editing, and submission of regulatory documents, ensuring compliance with all relevant requirements Monitor the evolving regulatory landscape for cell and gene therapy and communicate recommendations to management and project teams Required qualifications BS, MS, or PhD degree in a scientific discipline 5-7 years of experience in biotechnology with at least 3 years in Regulatory Affairs, or equivalent experience with advanced degrees Experience with biologic and/or gene therapy products preferred Knowledge of GCP, GLP, GMP, and FDA and ICH guidelines RAPS certification preferred but not required
...Custodian Position AvailableSt. Joseph Community School in New Hampton is seeking a dependable custodian to join our team! As a custodian, you will play a vital role in maintaining the cleanliness and functionality of our school facilities to create a welcoming and healthy...
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Regulatory Affairs Compliance ManagerPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating through... .... We are seeking a talented Regulatory Affairs Compliance Manager to join our team as a pivotal member that would play a key...
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...The Global Commodities Gas Trading Team helps clients manage risk and access liquidity. In this role, youll help build a durable U.S.... ...into actionable views, scenarios, and decision frameworks for Traders, Sales, and Structuring. Youll partner closely with Technology...