Senior Manager, Regulatory Affairs

Job description

Senior Manager, Regulatory Affairs At Hologic, we are driven by a clear purpose: advancing health through innovative medical technologies that improve and save lives. We are seeking an experienced Senior Manager, Regulatory Affairs to lead the Regulatory function at our Cambridge site. In this leadership role, you will oversee regulatory activities across a portfolio of innovative and established products. You will guide regulatory strategy, lead a high‑performing team, and partner with global and cross‑functional stakeholders to support product development, market access, and regulatory compliance. What To Expect: - Lead the Regulatory Affairs function at the Cambridge site and provide direction to the local regulatory team. - Develop and execute regulatory strategies for new product development and existing products, aligned with global regulatory requirements and company policies. - Drive regulatory submissions including pre‑clinical submissions, clinical trial applications, and marketing authorizations to support timely approvals. - Provide strategic regulatory guidance to cross‑functional teams and translate regulatory requirements into practical development plans. - Partner w...