Job Description The Manager of Regulatory Affairs will be responsible for the development, execution and tracking of regulatory submissions for assigned BicycleTx programs or projects. The Manager Regulatory Affairs may also be responsible for supporting the development of regulatory strategy and processes for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and senior members of the Regulatory Affairs team. As an integral member of the team that will be tasked with product development, the Manager Regulatory Affairs may also serve as a subject matter expert for assigned activities, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements. Responsible for the development and execution of global regulatory submissions for assigned BicycleTx programs or projects, including clinical trial applications Responsible for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions, responses to questions, audits and inspections May be responsible for the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned BicycleTx programs or projects, which may include selected key strategic submissions such as pediatric or orphan drug etc Developing and maintaining internal cross-functional relationships to support the development and execution of regulatory submissions for assigned BicycleTx programs or projects Supports the Global/Regional Regulatory Lead for assigned development programs May serve as primary contact with Health Authorities (HA) and/or external collaborators globally for assigned BicycleTx programs or projects. May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities Partners with Regulatory Affairs and cross-functional colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic-specific issues and adapts to changes that may impact BicycleTx programs or projects Responsible for maintaining oversight of current and pending relevant regulatory approvals in therapeutic areas relevant to the assigned BicycleTx programs or projects Accountable for maintaining working knowledge of laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge