Senior Manager Regulatory Affairs CMC

The Senior Manager, Regulatory Affairs CMC will be responsible for the development, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects. You will be responsible for supporting the development of CMC regulatory strategy and processes for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and the Director, Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development, the Senior Manager, Regulatory Affairs CMC will also serve as a subject matter expert (SME) 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 regulatory strategy and submissions for assigned BicycleTx programs or projects, with a focus on regulatory CMC, including dossiers to support clinical trial applications
• Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions
• Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections
• Manage the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND, IMPD, amendments and annual reports) for assigned BicycleTx programs or projects
• Developing and maintaining internal cross-functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programs or projects
• May act as the Global/Regional CMC Regulatory Lead for assigned development programs
• 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 CMC regulatory landscape, e.g., views of HAs, regulatory precedents, labeling differences and other CMC‑specific issues and adapts to changes that may impact BicycleTx programs or projects
• Accountable for maintaining working knowledge of CMC laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge

This is a hybrid working arrangement, with a minimum of 1-2 days onsite from our Cambridge, UK office. We are also open to those that can commit to a minimum of 0.8FTE (4 day week). We are only considering candidates who have a mix of CMC and Clinical Regulatory Affairs experience.